OneTouch Verio 022-657Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00353885008716), received between Dec 6, 2016 and Jun 14, 2023 — classified as 26 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (20 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON JUNE 09, 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) PORTUGAL, ALLEGING THAT HIS ONETOUCH VERIO 2 METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT ALLEGED THAT THE ISSUE STARTED ON (B)(6) 2023, WHEN HE RECEIVED THREE BLOOD GLUCOSE READINGS, BEFORE AND AFTER DINNER, ALL ABOVE ¿240 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT INDICATED THAT HE FELT THAT THE READINGS WERE NOT ACCURATE BUT DUE TO A HEART SURGERY RECENTLY, HE TRUSTED THE RESULTS. THE PATIENT MANAGES HIS DIABETES WITH UNSPECIFIED INSULIN (SELF-ADJUSTING DOSE ¿ USUAL DOSE BETWEEN 14-16 UNITS) AND CLAIMED THAT HE INCREASED HIS INSULIN INTAKE TO 20 UNITS AT 11 PM IN RESPONSE TO THE HIGH READINGS. DURING HIS SLEEP THE PATIENT WOKE BETWEEN 11:30 PM AND 12 AM TO USE THE BATHROOM AND STARTED FEELING ¿DIZZY AND FAINTED¿. THE PATIENT¿S WIFE ASSISTED HIM PROMPTLY AND TREATED HIM IMMEDIATELY WITH SUGAR PACKETS. THE PATIENT INDICATED THAT HE STARTED TO FEEL NORMAL AFTER. DURING TROUBLESHOOTING, THE CCA WAS NOT ABLE TO CONFIRM IF THE UNIT OF MEASURE WAS SET CO

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 17131860 ↗
• InjuryJun 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) PORTUGAL, ALLEGING THAT HIS ONETOUCH VERIO 2 METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT ALLEGED THAT THE ISSUE STARTED ON (B)(6) 2023, WHEN HE RECEIVED THREE BLOOD GLUCOSE READINGS, BEFORE AND AFTER DINNER, ALL ABOVE ¿240 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT INDICATED THAT HE FELT THAT THE READINGS WERE NOT ACCURATE BUT DUE TO A HEART SURGERY RECENTLY, HE TRUSTED THE RESULTS. THE PATIENT MANAGES HIS DIABETES WITH UNSPECIFIED INSULIN (SELF-ADJUSTING DOSE ¿ USUAL DOSE BETWEEN 14-16 UNITS) AND CLAIMED THAT HE INCREASED HIS INSULIN INTAKE TO 20 UNITS AT 11 PM IN RESPONSE TO THE HIGH READINGS. DURING HIS SLEEP THE PATIENT WOKE BETWEEN 11:30 PM AND 12 AM TO USE THE BATHROOM AND STARTED FEELING ¿DIZZY AND FAINTED¿. THE PATIENT¿S WIFE ASSISTED HIM PROMPTLY AND TREATED HIM IMMEDIATELY WITH SUGAR PACKETS. THE PATIENT INDICATED THAT HE STARTED TO FEEL NORMAL AFTER. DURING TROUBLESHOOTING, THE CCA WAS NOT ABLE TO CONFIRM IF THE UNIT OF MEASURE WAS SET CORR

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 17131859 ↗
• InjuryFeb 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, A HEALTHCARE PROFESSIONAL CONTACTED LIFESCAN (LFS) FRANCE ON BEHALF OF THE LAY USER/PATIENT, ALLEGING THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO THEIR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER CLAIMED THE ALLEGED METER INACCURACY BEGAN ON THE MORNING OF (B)(6) 2023. NO SPECIFIC READINGS WERE PROVIDED. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN. IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT¿S INSULIN DOSE WAS REPORTEDLY INCREASED BY 2 UNITS EVERY 48 HOURS. THE REPORTER CLAIMED THAT 11 DAYS AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT EXPERIENCED HYPOGLYCEMIA WITH SYMPTOMS OF ¿TROUBLES WHILE TALKING, HEAVY MOUTH¿. EMERGENCY MEDICAL SERVICES (EMS) WERE REPORTEDLY NOTIFIED FOR ASSISTANCE. THE REPORTER CLAIMED THAT WHEN EMS ARRIVED, THEY MEASURED THE PATIENT¿S BLOOD GLUCOSE WITH THE EMS METER AND RECEIVED A RESULT OF "34 MG/DL" AND ADMINISTERED A GLUCAGON INJECTION. REPLACEMENT PRODUCTS WERE PROVIDED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR AN ACUTE LOW BLOOD GLUCOSE EXCURSION AFTER OBTAINING ALLEGED INACCURATE HI

  Patient problems: Dysphasia; Hypoglycemia

  MAUDE report 16330063 ↗
• InjuryFeb 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, A HEALTHCARE PROFESSIONAL CONTACTED LIFESCAN (LFS) FRANCE ON BEHALF OF THE LAY USER/PATIENT, ALLEGING THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO THEIR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER CLAIMED THE ALLEGED METER INACCURACY BEGAN ON THE MORNING OF (B)(6) 2023. NO SPECIFIC READINGS WERE PROVIDED. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN. IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT¿S INSULIN DOSE WAS REPORTEDLY INCREASED BY 2 UNITS EVERY 48 HOURS. THE REPORTER CLAIMED THAT 11 DAYS AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT EXPERIENCED HYPOGLYCEMIA WITH SYMPTOMS OF ¿TROUBLES WHILE TALKING, HEAVY MOUTH¿. EMERGENCY MEDICAL SERVICES (EMS) WERE REPORTEDLY NOTIFIED FOR ASSISTANCE. THE REPORTER CLAIMED THAT WHEN EMS ARRIVED, THEY MEASURED THE PATIENT¿S BLOOD GLUCOSE WITH THE EMS METER AND RECEIVED A RESULT OF "34 MG/DL" AND ADMINISTERED A GLUCAGON INJECTION. REPLACEMENT PRODUCTS WERE PROVIDED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR AN ACUTE LOW BLOOD GLUCOSE EXCURSION AFTER OBTAINING ALLEGED INACCURATE HI

  Patient problems: Dysphasia; Hypoglycemia

  MAUDE report 16330051 ↗
• InjuryDec 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) FRANCE, ALLEGING THAT THEIR ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2022, AT 6:30 PM WHEN THEY OBTAINED AN ALLEGED HIGH RESULT OF ¿360 MG/DL¿ WITH THE SUBJECT METER, AND THE ISSUE CONTINUED FOR 1 WEEK. THE PATIENT USES NOVOMIX 30 INSULIN (6-8 UNITS MORNING AND EVENING) TO MANAGE THEIR DIABETES. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT'S NURSE CONTACTED THEIR DOCTOR WHO PRESCRIBED NOVORAPID INSULIN TO TAKE IN ADDITIONAL THEIR NORMAL MEDICATION. THE PATIENT CHANGED THEIR TREATMENT AS ADVISED BY THEIR NURSE AND DOCTOR, AND ON (B)(6) 2022, AT 6:30 PM AND (B)(6) 2022, AT 5:30 AM, THEY TOOK 5 UNITS OF NOVORAPID INSULIN IN ADDITION TO 16 UNITS OF NOVOMIX 30 INSULIN. THE PATIENT INDICATED THAT ON (B)(6) 2022, AT 11:30 AM, THEY DEVELOPED SYMPTOMS OF ¿COULDN'T SEE OR WALK PROPERLY¿ AND ¿WALKED TWISTED¿. IN RESPONSE TO THE SYMPTOMS, THE PATIENT TESTED THEIR BLOOD GLUCOSE ON ANOTHER METER AND OBTAINED A RESULT OF ¿54 MG/D

  Patient problems: Ambulation or Postural Difficulties; Hypoglycemia; Visual Impairment

  MAUDE report 15965653 ↗
• InjuryDec 12, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) FRANCE, ALLEGING THAT THEIR ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2022, AT 6:30 PM WHEN THEY OBTAINED AN ALLEGED HIGH RESULT OF ¿360 MG/DL¿ WITH THE SUBJECT METER, AND THE ISSUE CONTINUED FOR 1 WEEK. THE PATIENT USES NOVOMIX 30 INSULIN (6-8 UNITS MORNING AND EVENING) TO MANAGE THEIR DIABETES. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT'S NURSE CONTACTED THEIR DOCTOR WHO PRESCRIBED NOVORAPID INSULIN TO TAKE IN ADDITIONAL THEIR NORMAL MEDICATION. THE PATIENT CHANGED THEIR TREATMENT AS ADVISED BY THEIR NURSE AND DOCTOR, AND ON (B)(6) 2022, AT 6:30 PM AND (B)(6) 2022, AT 5:30 AM, THEY TOOK 5 UNITS OF NOVORAPID INSULIN IN ADDITION TO 16 UNITS OF NOVOMIX 30 INSULIN. THE PATIENT INDICATED THAT ON (B)(6) 2022, AT 11:30 AM, THEY DEVELOPED SYMPTOMS OF ¿COULDN'T SEE OR WALK PROPERLY¿ AND ¿WALKED TWISTED¿. IN RESPONSE TO THE SYMPTOMS, THE PATIENT TESTED THEIR BLOOD GLUCOSE ON ANOTHER METER AND OBTAINED A RESULT OF ¿54 MG/D

  Patient problems: Ambulation or Postural Difficulties; Hypoglycemia; Visual Impairment

  MAUDE report 15964927 ↗
• InjuryMar 29, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6), 2022, THE LAY-USER/PATIENT¿S RELATIVE CONTACTED LIFESCAN (LFS) (B)(6), ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY LOW. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE CCA DURING A FOLLOW-UP CALL WITH THE REPORTER. THE REPORTER STATED THAT ON THE MORNING OF (B)(6), 2022, THE PATIENT WOKE UP WITH SYMPTOMS OF ¿BLURRED VISION, DRY MOUTH, DISORIENTATION, BODY ACHES, REDNESS AND SHORTNESS OF BREATH¿. DURING THE FOLLOW-UP CALL, THE REPORTER RELATED THE SYMPTOMS TO A HIGH BLOOD GLUCOSE EXCURSION. IN RESPONSE TO THE SYMPTOMS, THE REPORTER CLAIMED THE PATIENT WENT DIRECTLY TO THE EMERGENCY ROOM (ER), WITHOUT MEASURING THEIR BLOOD GLUCOSE AT HOME, AND WAS HOSPITALIZED. THE REPORTER CONFIRMED THE PATIENT DID NOT PERFORM A BLOOD GLUCOSE TEST WITH THE SUBJECT METER THAT DAY. THE REPORTER WAS UNABLE TO CONFIRM IF THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED ON ARRIVAL AT ER. THE REPORTER INFORMED THE CCA THAT THE PATIENT WAS HOSPITALIZED FOR 3 WEEKS BECAUSE THEIR DIABETES WAS DYSREGULATED. THE REPORTER CLAIMED THAT DURING HOSPITALIZATION, IT WAS NECESSARY FOR THE PATIENT TO HAVE A COMPU

  Patient problems: Blurred Vision; Confusion/ Disorientation; Dry Mouth; Dyspnea; Hot Flashes/Flushes; Myalgia

  MAUDE report 13935057 ↗
• InjuryMar 29, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, THE LAY-USER/PATIENT¿S RELATIVE CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT¿S ONE TOUCH VERIO2 METER READ INACCURATELY LOW. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE CCA DURING A FOLLOW-UP CALL WITH THE REPORTER. THE REPORTER STATED THAT ON THE MORNING OF (B)(6) 2022, THE PATIENT WOKE UP WITH SYMPTOMS OF ¿BLURRED VISION, DRY MOUTH, DISORIENTATION, BODY ACHES, REDNESS AND SHORTNESS OF BREATH¿. DURING THE FOLLOW-UP CALL, THE REPORTER RELATED THE SYMPTOMS TO A HIGH BLOOD GLUCOSE EXCURSION. IN RESPONSE TO THE SYMPTOMS, THE REPORTER CLAIMED THE PATIENT WENT DIRECTLY TO THE EMERGENCY ROOM (ER), WITHOUT MEASURING THEIR BLOOD GLUCOSE AT HOME, AND WAS HOSPITALIZED. THE REPORTER CONFIRMED THE PATIENT DID NOT PERFORM A BLOOD GLUCOSE TEST WITH THE SUBJECT METER THAT DAY. THE REPORTER WAS UNABLE TO CONFIRM IF THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED ON ARRIVAL AT ER. THE REPORTER INFORMED THE CCA THAT THE PATIENT WAS HOSPITALIZED FOR 3 WEEKS BECAUSE THEIR DIABETES WAS DYSREGULATED. THE REPORTER CLAIMED THAT DURING HOSPITALIZATION, IT WAS NECESSARY FOR THE PATIENT TO HAVE A COMPUT

  Patient problems: Blurred Vision; Confusion/ Disorientation; Dry Mouth; Dyspnea; Hot Flashes/Flushes; Myalgia

  MAUDE report 13934945 ↗
• InjurySep 27, 2021Device Handling Problem; Device Handling Problem

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH VERIO2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN 1 WEEK PRIOR TO CONTACTING LFS; SHE WAS UNABLE TO RECALL THE EXACT DATE AND TIME. THE PATIENT REPORTED OBTAINING A BLOOD GLUCOSE READING OF 300 MG/DL WITH THE SUBJECT METER AND AFTER MORE THAN 20 MINUTES, SHE REMEASURED OBTAINING A READING OF "48 MG/DL." THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH INSULIN (NOVOMIX, TWICE DAILY) AND ORAL MEDICATION (METFORMIN, 2 PILLS). THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF DIZZINESS AND BAD FEELING AFTER THE READING OF 48 MG/DL" WAS OBTAINED; SHE WAS UNABLE RECALL EXACT TIME. THE PATIENT CLAIMED SHE WAS TREATED BY HER DAUGHTER WITH DEXTROSE . NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA

  Patient problems: Dizziness; Hypoglycemia; Malaise

  MAUDE report 12538102 ↗
• InjurySep 27, 2021Device Handling Problem; Device Handling Problem

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH VERIO2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN 1 WEEK PRIOR TO CONTACTING LFS; SHE WAS UNABLE TO RECALL THE EXACT DATE AND TIME. THE PATIENT REPORTED OBTAINING A BLOOD GLUCOSE READING OF ¿300 MG/DL¿ WITH THE SUBJECT METER AND AFTER MORE THAN 20 MINUTES, SHE REMEASURED OBTAINING A READING OF "48 MG/DL." THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH INSULIN (NOVOMIX, TWICE DAILY) AND ORAL MEDICATION (METFORMIN, 2 PILLS). THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿DIZZINESS AND BAD FEELING¿ AFTER THE READING OF ¿48 MG/DL" WAS OBTAINED; SHE WAS UNABLE RECALL EXACT TIME. THE PATIENT CLAIMED SHE WAS TREATED BY HER DAUGHTER WITH DEXTROSE . NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA

  Patient problems: Dizziness; Hypoglycemia; Malaise

  MAUDE report 12538100 ↗
• InjuryNov 23, 2020Device Handling Problem; Device Handling Problem

  ON (B)(6) 2020, THE LAY-USER/PATIENT'S SPOUSE CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT'S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (EMERGENCY MEDICAL SERVICES' METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6) 2020 AT 8:00 AM. THE REPORTER CLAIMED THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF "114 MG/DL" WITH THE SUBJECT METER THEN "29 MG/DL" ON THE OTHER DEVICE, PERFORMED MORE THAN 30 MINUTES APART. THE PATIENT MANAGES THEIR DIABETES WITH A FIXED DAILY DOSE OF 60 UNITS OF LANTUS INSULIN. THE REPORTER DENIED THE PATIENT MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER CLAIMED THAT 1 HOUR AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED A "DIABETIC COMA" AND THE EMERGENCY MEDICAL SERVICES (EMS) WERE NOTIFIED FOR ASSISTANCE. WHEN EMS ARRIVED, THE REPORTER CLAIMED THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION FOLLOWED BY JAM AND WAS THEN WAS TRANSPORTED TO HOSPITAL WHERE THEY REMAINED UNTIL 3:00 PM. THE REPORTER CLAIMED THE PATIENT'S BLOOD GLUCOSE TESTED "2

  Patient problems: Coma; Hypoglycemia

  MAUDE report 10885212 ↗
• InjuryNov 23, 2020Device Handling Problem; Device Handling Problem

  ON (B)(6) 2020, THE LAY-USER/PATIENT'S SPOUSE CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT'S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (EMERGENCY MEDICAL SERVICES' METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6) 2020 AT 8:00 AM. THE REPORTER CLAIMED THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF "114 MG/DL" WITH THE SUBJECT METER THEN "29 MG/DL" ON THE OTHER DEVICE, PERFORMED MORE THAN 30 MINUTES APART. THE PATIENT MANAGES THEIR DIABETES WITH A FIXED DAILY DOSE OF 60 UNITS OF LANTUS INSULIN. THE REPORTER DENIED THE PATIENT MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER CLAIMED THAT 1 HOUR AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED A "DIABETIC COMA" AND THE EMERGENCY MEDICAL SERVICES (EMS) WERE NOTIFIED FOR ASSISTANCE. WHEN EMS ARRIVED, THE REPORTER CLAIMED THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION FOLLOWED BY JAM AND WAS THEN WAS TRANSPORTED TO HOSPITAL WHERE THEY REMAINED UNTIL 3:00 PM. THE REPORTER CLAIMED THE PATIENT'S BLOOD GLUCOSE TESTED "2

  Patient problems: Coma; Hypoglycemia

  MAUDE report 10885167 ↗
• InjuryNov 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2020 AT 7:18 PM, SHE OBTAINED WHAT SHE FELT WAS AN INACCURATE HIGH BLOOD GLUCOSE READING OF "444 MG/DL" WITH THE SUBJECT METER. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN 700 MG THREE TIMES A DAY) AND INSULIN (20 UNITS NOVOLOG AFTER LUNCH; 20-30 UNITS OF TOUJEO BEFORE BED BASED ON FOOD INTAKE). WHEN SHE OBTAINED THE ELEVATED RESULT, THE PATIENT CLAIMED SHE TOOK AN EXTRA DOSE OF 20 UNITS OF NOVOLOG INSULIN. THE PATIENT CLAIMED SHE RETESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED RESULTS OF "427, 371, 307 AND 373 MG/DL" AT 7:28 PM, 7:43 PM, 8:11 PM AND 8:30 PM RESPECTIVELY. THE PATIENT STATED THAT SHE BEGAN TO DEVELOP SYMPTOMS OF FEELING "WEAK, NO ENERGY, LOST MEMORY, CONFUSION AND CAN'T TALK" AT 8:30 PM. THE PATIENT CLAIMED HER DAUGHTER CONTACTED THE EMERGENCY ROOM FOR ASSISTANCE AND WAS INSTRUCTED TO TAKE HER TO HOSPITAL. HOW

  Patient problems: Confusion/ Disorientation; Dysphasia; Fatigue; Memory Loss/Impairment

  MAUDE report 10810160 ↗
• InjuryNov 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2020 AT 7:18 PM, SHE OBTAINED WHAT SHE FELT WAS AN INACCURATE HIGH BLOOD GLUCOSE READING OF "444 MG/DL" WITH THE SUBJECT METER. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN 700 MG THREE TIMES A DAY) AND INSULIN (20 UNITS NOVOLOG AFTER LUNCH; 20-30 UNITS OF TOUJEO BEFORE BED BASED ON FOOD INTAKE). WHEN SHE OBTAINED THE ELEVATED RESULT, THE PATIENT CLAIMED SHE TOOK AN EXTRA DOSE OF 20 UNITS OF NOVOLOG INSULIN. THE PATIENT CLAIMED SHE RETESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED RESULTS OF "427, 371, 307 AND 373 MG/DL" AT 7:28 PM, 7:43 PM, 8:11 PM AND 8:30 PM RESPECTIVELY. THE PATIENT STATED THAT SHE BEGAN TO DEVELOP SYMPTOMS OF FEELING "WEAK, NO ENERGY, LOST MEMORY, CONFUSION AND CAN'T TALK" AT 8:30 PM. THE PATIENT CLAIMED HER DAUGHTER CONTACTED THE EMERGENCY ROOM FOR ASSISTANCE AND WAS INSTRUCTED TO TAKE HER TO HOSPITAL. HOW

  Patient problems: Confusion/ Disorientation; Dysphasia; Fatigue; Memory Loss/Impairment

  MAUDE report 10810149 ↗
• InjurySep 24, 2020Device Handling Problem; Device Handling Problem

  ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HIS ONETOUCH VERIO2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2020. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "291 AND 288 MG/DL" WITH THE SUBJECT METER, PERFORMED MORE THAN 20 MINUTES APART. THE PATIENT STATED THAT HE USUALLY MANAGES HIS DIABETES WITH 14 UNITS OF HUMALOG INSULIN. THE PATIENT CLAIMED HE TOOK AN INCREASED DOSE OF 24 UNITS OF INSULIN ON (B)(6) 2020 IN RESPONSE TO THE ALLEGED INACCURATE RESULTS. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF "SWEATING, SHAKING AND CAN'T SLEEP" AT AN UNSPECIFIED TIME ON (B)(6) 2020, BUT DENIED RECEIVING MEDICAL TREATMENT. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THAT THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE T

  Patient problems: Diaphoresis; Shaking/Tremors; Sleep Dysfunction

  MAUDE report 10579022 ↗
• InjurySep 24, 2020Device Handling Problem; Device Handling Problem

  ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HIS ONETOUCH VERIO2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2020. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "291 AND 288 MG/DL" WITH THE SUBJECT METER, PERFORMED MORE THAN 20 MINUTES APART. THE PATIENT STATED THAT HE USUALLY MANAGES HIS DIABETES WITH 14 UNITS OF HUMALOG INSULIN. THE PATIENT CLAIMED HE TOOK AN INCREASED DOSE OF 24 UNITS OF INSULIN ON (B)(6) 2020 IN RESPONSE TO THE ALLEGED INACCURATE RESULTS. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF "SWEATING, SHAKING AND CAN'T SLEEP" AT AN UNSPECIFIED TIME ON (B)(6) 2020, BUT DENIED RECEIVING MEDICAL TREATMENT. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THAT THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE T

  Patient problems: Diaphoresis; Shaking/Tremors; Sleep Dysfunction

  MAUDE report 10579021 ↗
• InjuryMay 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED HIS FEELINGS AND/OR NORMAL READINGS AND COMPARED TO ANOTHER METER (PARAMEDIC¿S METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED ISSUE OCCURRED EARLY MORNING ON (B)(6) 2020. THE REPORTER CLAIMED THE PATIENT OBTAINED WHAT HE FELT WAS AN INACCURATE HIGH RESULT OF ¿243 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (METFORMIN 500 MG 1 PILL DAILY). THE REPORTER DENIED THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ELEVATED READING. THE REPORTER CLAIMED THAT EARLY MORNING ON (B)(6) 2020, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF ¿SWEATING, CONFUSION AND COMATOSE.¿ THE EMERGENCY MEDICAL SERVICES WERE CONTACTED FOR ASSISTANCE. THE REPORTER CLAIMED THAT ON THEIR ARRIVAL, THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED AT ¿10 MG/DL¿ ON THE PARAMEDIC¿S DEVICE. THE TIME DIFFERENCE BETWEEN THE LIFESCAN METER READING AND PARAMEDIC¿S METER READING WAS NOT PROVI

  Patient problems: Coma; Confusion/ Disorientation; Sweating

  MAUDE report 10055031 ↗
• InjuryMay 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED HIS FEELINGS AND/OR NORMAL READINGS AND COMPARED TO ANOTHER METER (PARAMEDIC¿S METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2020. THE REPORTER CLAIMED THAT ON (B)(6) 2020, THE PATIENT OBTAINED WHAT HE FELT WERE INACCURATE HIGH READINGS IN THE ¿200S MG/DL¿ RANGE WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (METFORMIN 500 MG 1 PILL DAILY). THE REPORTER DENIED THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ELEVATED READINGS. THE REPORTER CLAIMED THAT AT THE TIME OF THE ALLEGED ISSUE ON (B)(6) 2020, THE PATIENT DEVELOPED SYMPTOMS OF ¿LOW BLOOD GLUCOSE AND COULDN¿T BREATHE.¿ SOON AFTER THE ONSET OF THE SYMPTOMS, THE EMERGENCY MEDICAL SERVICES WERE CONTACTED FOR ASSISTANCE. ON THEIR ARRIVAL, THE PATIENT¿S BLOOD GLUCOSE WAS REPORTEDLY MEASURED AT ¿27 MG/DL¿ ON THE PARAMEDIC¿S DEVICE. THE TIME DIFFERENCE BETWEEN THE LIFESCAN METER READING

  Patient problems: Dyspnea; Hypoglycemia

  MAUDE report 10055030 ↗
• InjuryMay 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED HIS FEELINGS AND/OR NORMAL READINGS AND COMPARED TO ANOTHER METER (PARAMEDIC¿S METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED ISSUE OCCURRED EARLY MORNING ON (B)(6) 2020. THE REPORTER CLAIMED THE PATIENT OBTAINED WHAT HE FELT WAS AN INACCURATE HIGH RESULT OF ¿243 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (METFORMIN 500 MG 1 PILL DAILY). THE REPORTER DENIED THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ELEVATED READING. THE REPORTER CLAIMED THAT EARLY MORNING ON (B)(6) 2020, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF ¿SWEATING, CONFUSION AND COMATOSE.¿ THE EMERGENCY MEDICAL SERVICES WERE CONTACTED FOR ASSISTANCE. THE REPORTER CLAIMED THAT ON THEIR ARRIVAL, THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED AT ¿10 MG/DL¿ ON THE PARAMEDIC¿S DEVICE. THE TIME DIFFERENCE BETWEEN THE LIFESCAN METER READING AND PARAMEDIC¿S METER READING WAS NOT PROVI

  Patient problems: Coma; Confusion/ Disorientation; Sweating

  MAUDE report 10055029 ↗
• InjuryMay 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED HIS FEELINGS AND/OR NORMAL READINGS AND COMPARED TO ANOTHER METER (PARAMEDIC¿S METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2020. THE REPORTER CLAIMED THAT ON (B)(6) 2020, THE PATIENT OBTAINED WHAT HE FELT WERE INACCURATE HIGH READINGS IN THE ¿200S MG/DL¿ RANGE WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (METFORMIN 500 MG 1 PILL DAILY). THE REPORTER DENIED THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ELEVATED READINGS. THE REPORTER CLAIMED THAT AT THE TIME OF THE ALLEGED ISSUE ON (B)(6) 2020, THE PATIENT DEVELOPED SYMPTOMS OF ¿LOW BLOOD GLUCOSE AND COULDN¿T BREATHE.¿ SOON AFTER THE ONSET OF THE SYMPTOMS, THE EMERGENCY MEDICAL SERVICES WERE CONTACTED FOR ASSISTANCE. ON THEIR ARRIVAL, THE PATIENT¿S BLOOD GLUCOSE WAS REPORTEDLY MEASURED AT ¿27 MG/DL¿ ON THE PARAMEDIC¿S DEVICE. THE TIME DIFFERENCE BETWEEN THE LIFESCAN METER READING

  Patient problems: Dyspnea; Hypoglycemia

  MAUDE report 10055028 ↗
• InjuryMar 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)( 2020, THE LAY USER/PATIENT¿S PHARMACIST CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE CONTACTED FOR ADDITIONAL INFORMATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED AT AN UNSPECIFIED TIME ON (B)(6) 2020 WHEN THE PATIENT OBTAINED A RESULT OF ¿477 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF INSULIN (APIDRA AND TOUJEO) AND METFORMIN MEDICATION. IN RESPONSE TO THE ELEVATED RESULT, THE REPORTER CLAIMED THE PATIENT TOOK AN INCREASED DOSE OF INSULIN (TYPE AND DOSE NOT REPORTED). THE REPORTER CLAIMED THAT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF ¿DIDN¿T FEEL GOOD AND STARTED SHAKING.¿ THE REPORTER WAS UNABLE TO CONFIRM IF THE PATIENT RECEIVED ANY TREATMENT FOR THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CSA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO P

  Patient problems: Malaise; Shaking/Tremors

  MAUDE report 9806337 ↗
• InjuryMar 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, THE LAY USER/PATIENT¿S PHARMACIST CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE CONTACTED FOR ADDITIONAL INFORMATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED AT AN UNSPECIFIED TIME ON (B)(6) 2020 WHEN THE PATIENT OBTAINED A RESULT OF ¿477 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF INSULIN (APIDRA AND TOUJEO) AND METFORMIN MEDICATION. IN RESPONSE TO THE ELEVATED RESULT, THE REPORTER CLAIMED THE PATIENT TOOK AN INCREASED DOSE OF INSULIN (TYPE AND DOSE NOT REPORTED). THE REPORTER CLAIMED THAT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF ¿DIDN¿T FEEL GOOD AND STARTED SHAKING.¿ THE REPORTER WAS UNABLE TO CONFIRM IF THE PATIENT RECEIVED ANY TREATMENT FOR THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CSA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO

  Patient problems: Malaise; Shaking/Tremors

  MAUDE report 9806336 ↗
• InjuryJan 31, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY BEGAN DURING (B)(6) 2019 WHEN THE PATIENT STARTED TO OBTAIN HIGHER RESULTS THAN USUAL. THE REPORTER CLAIMED THE PATIENT OBTAINED ALLEGED INACCURATE HIGH RESULTS OF ¿180, 250 AND 280 MG/DL¿ WITH THE SUBJECT METER. HE PATIENT MANAGES HIS DIABETES WITH 22 UNITS OF LANTUS INSULIN IN THE MORNING. IN RESPONSE TO THE ELEVATED RESULTS, THE PATIENT CLAIMED HE WENT TO HIS DIABETOLOGIST WHO REFERRED HIM TO HOSPITAL. THE PATIENT REPORTEDLY RECEIVED RAPID INSULIN AND WAS HOSPITALIZED FOR 10 DAYS. THE REPORTER CLAIMED THAT AROUND (B)(6) 2019, AFTER THE PATIENT LEFT HOSPITAL, HE STARTED TO TAKE BETWEEN 4-6 UNITS OF RAPID INSULIN BASED ON METER RESULTS. THE REPORTER STATED THAT AROUND APRIL 13 TO APRIL 15, 2019, THE PATIENT DEVELOPED SYMPTOMS OF ¿LOST WEIGHT, VERY YELLOW SKIN, BAD MOOD, COULDN¿T WALK PROPERLY AND LOST CONSCIOUSNESS.¿ THE EMERGENCY MEDICAL S

  Patient problems: Ambulation or Postural Difficulties; Irritability; Loss of consciousness

  MAUDE report 9652318 ↗
• InjuryJan 31, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON JANUARY 7, 2020, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY BEGAN DURING (B)(6) 2019 WHEN THE PATIENT STARTED TO OBTAIN HIGHER RESULTS THAN USUAL. THE REPORTER CLAIMED THE PATIENT OBTAINED ALLEGED INACCURATE HIGH RESULTS OF ¿180, 250 AND 280 MG/DL¿ WITH THE SUBJECT METER. HE PATIENT MANAGES HIS DIABETES WITH 22 UNITS OF LANTUS INSULIN IN THE MORNING. IN RESPONSE TO THE ELEVATED RESULTS, THE PATIENT CLAIMED HE WENT TO HIS DIABETOLOGIST WHO REFERRED HIM TO HOSPITAL. THE PATIENT REPORTEDLY RECEIVED RAPID INSULIN AND WAS HOSPITALIZED FOR 10 DAYS. THE REPORTER CLAIMED THAT AROUND (B)(6) 2019, AFTER THE PATIENT LEFT HOSPITAL, HE STARTED TO TAKE BETWEEN 4-6 UNITS OF RAPID INSULIN BASED ON METER RESULTS. THE REPORTER STATED THAT AROUND (B)(6) 2019, THE PATIENT DEVELOPED SYMPTOMS OF ¿LOST WEIGHT, VERY YELLOW SKIN, BAD MOOD, COULDN¿T WALK PROPERLY AND LOST CONSCIOUSNESS.¿ THE EMERGENCY MEDICAL SERVICES WER

  Patient problems: Ambulation or Postural Difficulties; Irritability; Loss of consciousness

  MAUDE report 9652315 ↗
• InjuryNov 14, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, A REPORTER FOR THE PATIENT (THE PATIENT¿S PHARMACIST) CONTACTED LIFESCAN (LFS) (B)(6) , ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO 2 METER DISPLAYED INACCURATELY HIGH RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, AFTER ADDITIONAL INFORMATION WAS OBTAINED DIRECTLY FROM THE PATIENT DURING A FOLLOW-UP CALL ON (B)(6) 2019. THE PATIENT REPORTED THAT SHE HAD OBTAINED HIGH READINGS ON THE SUBJECT METER FOR ABOUT A WEEK PRIOR TO CONTACTING LFS. SHE STATED THAT AT 00:10AM ON NOVEMBER 9, 2019, SHE TESTED HER BLOOD GLUCOSE LEVEL USING THE SUBJECT METER AND OBTAINED A RESULT OF ¿243MG/DL¿, WHICH, WITH HINDSIGHT, SHE CONSIDERS TO HAVE BEEN TOO HIGH. THE PATIENT MANAGES HER DIABETES WITH DAILY DOSES OF 7 UNITS OF APIDRA AND 20 UNITS OF LEVEMIR INSULIN. SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AFTER OBTAINING THE REPORTED RESULT. SHE STATED THAT AROUND 4AM ON (B)(6) 2019, SHE DEVELOPED SYMPTOMS OF ¿HYPERTENSION, HYPOTHERMIA, EYESIGHT ISSUE, HEARING ISSUE, CONVULSIONS, TREMBLING AND A BRIEF LOSS OF CONSCIOUSNESS¿ WHICH SHE ASSOCIATED WITH HYPOGLYCEMIA. SHE REPORTED THAT THE EMERGENCY MEDICAL SER

  Patient problems: Deafness; High Blood Pressure/ Hypertension; Hypothermia; Loss of consciousness; No Code Available; Seizures; Shaking/Tremors

  MAUDE report 9321376 ↗