OneTouch Verio Reflect 023-927Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00353885011693), received between Sep 17, 2020 and Sep 28, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON SEPTEMBER 15, 2023, THE LAY USER/PATIENT¿S RELATIVE CONTACTED LIFESCAN (LFS) ITALY, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER READ INACCURATELY LOW COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS AND COMPARED TO AN EMERGENCY MEDICAL SERVICE METER. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE REPORTER. THE REPORTER STATED THAT ON (B)(6) 2023, AT 10:00 AM, THE PATIENT MEASURED HIS BLOOD GLUCOSE WITH THE SUBJECT METER IN RESPONSE TO SYMPTOMS OF ¿NOT FEELING WELL¿ AND OBTAINED AN ALLEGED LOW RESULT OF ¿40 MG/DL¿. THE REPORTER WAS UNABLE TO PROVIDE INFORMATION ON THE SPECIFIC SYMPTOMS FELT AT THAT TIME. THE REPORTER MENTIONED THAT THE PATIENT IS ASSISTED DAILY BY A CARER. THE REPORTER ADVISED THAT THE PATIENT PERFORMS BLOOD GLUCOSE MONITORING ONCE A DAY, 6 OR 7 TIMES A WEEK AND THAT HE TAKES ORAL THERAPY (TYPE/DOSE NOT REPORTED) AND A ONCE DAILY DOSE OF INSULIN TO MANAGE HIS DIABETES. DURING THE FOLLOW-UP CALL, THE REPORTER CLAIMED THAT IN THE DAYS PRIOR TO THE ALLEGED ISSUE, THE PATIENT WAS RECEIVING BLOOD GLUCOSE RESULTS OF AROUND ¿380 TO 400 MG/DL¿. AS A RESULT OF THE ALLEGED

  Patient problems: Alteration in Body Temperature; Apnea; Dehydration; Hyperglycemia; Muscle Weakness/Atrophy; Pallor; Polydipsia; Syncope/Fainting

  MAUDE report 17840507 ↗
• InjurySep 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, THE LAY USER/PATIENT¿S RELATIVE CONTACTED LIFESCAN (LFS) ITALY, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER READ INACCURATELY LOW COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS AND COMPARED TO AN EMERGENCY MEDICAL SERVICE METER. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE REPORTER. THE REPORTER STATED THAT ON (B)(6) 2023, AT 10:00 AM, THE PATIENT MEASURED HIS BLOOD GLUCOSE WITH THE SUBJECT METER IN RESPONSE TO SYMPTOMS OF ¿NOT FEELING WELL¿ AND OBTAINED AN ALLEGED LOW RESULT OF ¿40 MG/DL¿. THE REPORTER WAS UNABLE TO PROVIDE INFORMATION ON THE SPECIFIC SYMPTOMS FELT AT THAT TIME. THE REPORTER MENTIONED THAT THE PATIENT IS ASSISTED DAILY BY A CARER. THE REPORTER ADVISED THAT THE PATIENT PERFORMS BLOOD GLUCOSE MONITORING ONCE A DAY, 6 OR 7 TIMES A WEEK AND THAT HE TAKES ORAL THERAPY (TYPE/DOSE NOT REPORTED) AND A ONCE DAILY DOSE OF INSULIN TO MANAGE HIS DIABETES. DURING THE FOLLOW-UP CALL, THE REPORTER CLAIMED THAT IN THE DAYS PRIOR TO THE ALLEGED ISSUE, THE PATIENT WAS RECEIVING BLOOD GLUCOSE RESULTS OF AROUND ¿380 TO 400 MG/DL¿. AS A RESULT OF THE ALLEGED INACCUR

  Patient problems: Alteration in Body Temperature; Apnea; Dehydration; Hyperglycemia; Muscle Weakness/Atrophy; Pallor; Polydipsia; Syncope/Fainting

  MAUDE report 17840499 ↗
• InjuryOct 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ITALY, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER DISPLAYED INACCURATE READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE CONTACTED FOR FURTHER INFORMATION. IT WAS NOT REPORTED WHEN THE ALLEGED METER INACCURACY BEGAN. THE REPORTER WAS UNABLE TO PROVIDE THE ALLEGED INACCURATE RESULTS OBTAINED WITH THE SUBJECT METER. IT IS NOT KNOWN HOW THE PATIENT MANAGES THEIR DIABETES OR IF THEY MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER CLAIMED THE PATIENT EXPERIENCED ¿HYPOGLYCEMIA¿ AFTER THE ALLEGED ISSUE BEGAN AND RECEIVED UNSPECIFIED TREATMENT BY EMERGENCY MEDICAL SERVICES. THE REPORTER WAS UNABLE TO PROVIDE FURTHER INFORMATION. TROUBLESHOOTING WAS UNABLE TO BE PERFORMED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR AN ACUTE LOW BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED ISSUE BEGAN. THERE IS INSUFFICIENT INFORMATION TO RULE OUT THE CONTRIBUTION OF THE SUBJECT METER TO THE EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 15643320 ↗
• InjuryOct 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ITALY, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER DISPLAYED INACCURATE READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE CONTACTED FOR FURTHER INFORMATION. IT WAS NOT REPORTED WHEN THE ALLEGED METER INACCURACY BEGAN. THE REPORTER WAS UNABLE TO PROVIDE THE ALLEGED INACCURATE RESULTS OBTAINED WITH THE SUBJECT METER. IT IS NOT KNOWN HOW THE PATIENT MANAGES THEIR DIABETES OR IF THEY MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER CLAIMED THE PATIENT EXPERIENCED ¿HYPOGLYCEMIA¿ AFTER THE ALLEGED ISSUE BEGAN AND RECEIVED UNSPECIFIED TREATMENT BY EMERGENCY MEDICAL SERVICES. THE REPORTER WAS UNABLE TO PROVIDE FURTHER INFORMATION. TROUBLESHOOTING WAS UNABLE TO BE PERFORMED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR AN ACUTE LOW BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED ISSUE BEGAN. THERE IS INSUFFICIENT INFORMATION TO RULE OUT THE CONTRIBUTION OF THE SUBJECT METER TO THE EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 15643319 ↗
• InjuryDec 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ITALY, ALLEGING THAT HER ONETOUCH VERIO REFLECT METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (RIGHT METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN AROUND 10 DAYS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿150, 250 AND 130 MG/DL¿ WITH THE SUBJECT METER COMPARED TO ¿90, 170 AND 66 MG/DL¿ RESPECTIVELY ON THE OTHER DEVICE. THE COMPARATIVE RESULTS WERE OBTAINED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH INSULIN THREE TIMES A DAY ON A SELF-ADJUSTING DOSE. IT WAS NOT REPORTED IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED THAT SHE STARTED TO ¿TREMBLE AND SWEAT¿ ON (B)(6) 2021 AT 11:55 PM. THE PATIENT CLAIMED SHE TREATED HERSELF WITH SUGAR AT THE ONSET OF SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED AN APPROVED SAMPLE SITE WAS USED FOR TESTING AND THE CORRECT TESTING PROCESS WAS BE

  Patient problems: Diaphoresis; Shaking/Tremors

  MAUDE report 13057214 ↗
• InjuryDec 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH VERIO REFLECT METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (RIGHT METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN AROUND 10 DAYS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿150, 250 AND 130 MG/DL¿ WITH THE SUBJECT METER COMPARED TO ¿90, 170 AND 66 MG/DL¿ RESPECTIVELY ON THE OTHER DEVICE. THE COMPARATIVE RESULTS WERE OBTAINED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH INSULIN THREE TIMES A DAY ON A SELF-ADJUSTING DOSE. IT WAS NOT REPORTED IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED THAT SHE STARTED TO ¿TREMBLE AND SWEAT¿ ON (B)(6) 2021 AT 11:55 PM. THE PATIENT CLAIMED SHE TREATED HERSELF WITH SUGAR AT THE ONSET OF SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED AN APPROVED SAMPLE SITE WAS USED FOR TESTING AND THE CORRECT TESTING PROCESS WAS B

  Patient problems: Diaphoresis; Shaking/Tremors

  MAUDE report 13057211 ↗
• InjuryAug 20, 2021Device Handling Problem; Device Handling Problem

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH VERIO REFLECT METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON FURTHER INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT WHEN SHE WENT TO BED ON (B)(6) 2021 AT 1:20 AM, SHE FELT VERY BAD; SHE REPORTED SYMPTOMS OF ¿SWEATING AND SUFFOCATION.¿ IN RESPONSE TO HOW SHE WAS FEELING, THE PATIENT CLAIMED SHE TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED ALLEGED INACCURATE READINGS OF ¿55, 101, 102 THEN 110 MG/DL,¿ PERFORMED MORE THAN 20 MINUTES APART. THE PATIENT CLAIMED THAT WHEN THE READING OF ¿55 MG/DL¿ WAS OBTAINED, SHE STARTED TO TREAT HERSELF WITH SUGAR WATER/COCA COLA AND CONTINUED TO EAT/DRINK UNTIL 3:30 AM WHEN SHE FELL ASLEEP; HOWEVER, THE PATIENT DENIED FEELING BETTER AFTER TREATMENT. DURING THE FOLLOW-UP CALL, THE PATIENT CLAIMED SHE ASSOCIATED THE REPORTED SYMPTOMS WITH A HIGH BLOOD GLUCOSE EXCURSION; THE SYMPTOMS WERE TYPICAL FOR HER WHEN RUNNING HIGH. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF INSULIN (TOUJEO 20 UNITS ONCE DAILY; HUMALOG THREE TIMES A DAY). THE

  Patient problems: Diaphoresis; Dyspnea

  MAUDE report 12351557 ↗
• InjuryAug 20, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH VERIO REFLECT METER READ INACCURATELY LOW COMPARED TO ANOTHER METER (ONETOUCH VERIO REFLECT). THE COMPLAINT WAS CLASSIFIED BASED ON FURTHER INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY OCCURRED AT LUNCHTIME ON (B)(6) 2021. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿110, 101 AND 104 MG/DL¿ WITH THE SUBJECT METER AND ¿450 AND 480 MG/DL¿ ON THE OTHER DEVICE, PERFORMED WITHIN AN UNSPECIFIED TIME OF EACH OTHER. PRIOR TO THE ALLEGED ISSUE, THE PATIENT REPORTED WAKING UP LATE MORNING ON (B)(6) 2021 WITH SYMPTOMS OF ¿SWEATING AND SUFFOCATION.¿ THE PATIENT DENIED RECEIVING ANY TREATMENT ABOVE AND BEYOND HER USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT DUE TO THE ALLEGED ISSUE. DURING THE FOLLOW-UP CALL, THE PATIENT CLAIMED SHE ASSOCIATED THE REPORTED SYMPTOMS WITH A HIGH BLOOD GLUCOSE EXCURSION; THE SYMPTOMS WERE TYPICAL FOR HER WHEN RUNNING HIGH. AT THE ONSET OF SYMPTOMS, THE PATIENT CLAIMED HER BLOOD GLUCOSE MEASURED ¿120 MG/DL¿ WITH THE SUBJECT METER COMPARED TO ¿480 MG/DL

  Patient problems: Diaphoresis; Dyspnea; Hyperglycemia

  MAUDE report 12351555 ↗
• InjuryAug 20, 2021Device Handling Problem; Device Handling Problem

  ON AUGUST 12, 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH VERIO REFLECT METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON FURTHER INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT WHEN SHE WENT TO BED ON (B)(6) 2021 AT 1:20 AM, SHE FELT VERY BAD; SHE REPORTED SYMPTOMS OF ¿SWEATING AND SUFFOCATION.¿ IN RESPONSE TO HOW SHE WAS FEELING, THE PATIENT CLAIMED SHE TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED ALLEGED INACCURATE READINGS OF ¿55, 101, 102 THEN 110 MG/DL,¿ PERFORMED MORE THAN 20 MINUTES APART. THE PATIENT CLAIMED THAT WHEN THE READING OF ¿55 MG/DL¿ WAS OBTAINED, SHE STARTED TO TREAT HERSELF WITH SUGAR WATER/(B)(6) AND CONTINUED TO EAT/DRINK UNTIL 3:30 AM WHEN SHE FELL ASLEEP; HOWEVER, THE PATIENT DENIED FEELING BETTER AFTER TREATMENT. DURING THE FOLLOW-UP CALL, THE PATIENT CLAIMED SHE ASSOCIATED THE REPORTED SYMPTOMS WITH A HIGH BLOOD GLUCOSE EXCURSION; THE SYMPTOMS WERE TYPICAL FOR HER WHEN RUNNING HIGH. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF INSULIN (TOUJEO 20 UNITS ONCE DAILY; HUMALOG THREE TIMES A DAY). THE

  Patient problems: Diaphoresis; Dyspnea

  MAUDE report 12351552 ↗
• InjuryAug 20, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ITALY, ALLEGING THAT HER ONETOUCH VERIO REFLECT METER READ INACCURATELY LOW COMPARED TO ANOTHER METER (ONETOUCH VERIO REFLECT). THE COMPLAINT WAS CLASSIFIED BASED ON FURTHER INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY OCCURRED AT LUNCHTIME ON (B)(6) 2021. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿110, 101 AND 104 MG/DL¿ WITH THE SUBJECT METER AND ¿450 AND 480 MG/DL¿ ON THE OTHER DEVICE, PERFORMED WITHIN AN UNSPECIFIED TIME OF EACH OTHER. PRIOR TO THE ALLEGED ISSUE, THE PATIENT REPORTED WAKING UP LATE MORNING ON (B)(6) 2021 WITH SYMPTOMS OF ¿SWEATING AND SUFFOCATION.¿ THE PATIENT DENIED RECEIVING ANY TREATMENT ABOVE AND BEYOND HER USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT DUE TO THE ALLEGED ISSUE. DURING THE FOLLOW-UP CALL, THE PATIENT CLAIMED SHE ASSOCIATED THE REPORTED SYMPTOMS WITH A HIGH BLOOD GLUCOSE EXCURSION; THE SYMPTOMS WERE TYPICAL FOR HER WHEN RUNNING HIGH. AT THE ONSET OF SYMPTOMS, THE PATIENT CLAIMED HER BLOOD GLUCOSE MEASURED ¿120 MG/DL¿ WITH THE SUBJECT METER COMPARED TO ¿480 MG/DL¿

  Patient problems: Diaphoresis; Dyspnea; Hyperglycemia

  MAUDE report 12351550 ↗
• InjurySep 17, 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 VERIO REFLECT 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 ON (B)(6) 2020 AT 10:00 PM. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "235 AND 155 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH UNSPECIFIED INSULIN TAKEN TWICE DAILY (SELF-ADJUSTER). THE PATIENT DENIED TAKING ANY ACTION ANY ACTION WITH REGARDS TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURATE RESULTS. THE PATIENT REPORTED THAT ON THE EVENING OF (B)(6) 2020, AFTER THE ALLEGED ISSUE BEGAN, SHE "LOST CONSCIOUSNESS." THE PATIENT CLAIMED HER DAUGHTER GAVE HER JAM WHILE SHE WAS LOSING CONSCIOUSNESS AND CONTACTED THE EMERGENCY MEDICAL SERVICES (EMS) FOR ASSISTANCE. THE PATIENT CLAIMED THAT WHEN EMS ARRIVED, HER BLOOD GLUCOSE TESTED "44 MG/DL" ON THE EMS DEVICE AND THAT SHE WAS ADVISED TO TAKE MORE SUGAR AND BREAD. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECT

  Patient problems: Syncope/Fainting

  MAUDE report 10545586 ↗
• InjurySep 17, 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 VERIO REFLECT 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 ON (B)(6) 2020 AT 10:00 PM. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "235 AND 155 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH UNSPECIFIED INSULIN TAKEN TWICE DAILY (SELF-ADJUSTER). THE PATIENT DENIED TAKING ANY ACTION ANY ACTION WITH REGARDS TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURATE RESULTS. THE PATIENT REPORTED THAT ON THE EVENING OF (B)(6) 2020, AFTER THE ALLEGED ISSUE BEGAN, SHE "LOST CONSCIOUSNESS." THE PATIENT CLAIMED HER DAUGHTER GAVE HER JAM WHILE SHE WAS LOSING CONSCIOUSNESS AND CONTACTED THE EMERGENCY MEDICAL SERVICES (EMS) FOR ASSISTANCE. THE PATIENT CLAIMED THAT WHEN EMS ARRIVED, HER BLOOD GLUCOSE TESTED "44 MG/DL" ON THE EMS DEVICE AND THAT SHE WAS ADVISED TO TAKE MORE SUGAR AND BREAD. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECT

  Patient problems: Syncope/Fainting

  MAUDE report 10545583 ↗