OneTouch Ultra2 024-046Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00353885011853), received between Aug 18, 2022 and Apr 24, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryApr 24, 2026Device Alarm System

  ON (B)(6) 2026, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THEIR ONETOUCH ULTRA2 METER CONTINUED TO DISPLAY THE APPLY SAMPLE MESSAGE INSTEAD OF COUNTING DOWN AND PROVIDING A BLOOD GLUCOSE RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING, SINCE THE PATIENT DISCONNECTED THE CALL AND COULD NOT BE REACHED FOR FURTHER INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED METER ISSUE BEGAN 2 WEEKS AGO AROUND 8:00 AM TO 9:00 AM. THE PATIENT MANAGES THEIR DIABETES WITH LANTUS INSULIN (20-25 UNITS) AND HUMALOG INSULIN ON A SELF-ADJUSTING DOSE. THE PATIENT DID NOT REPORT TAKING ANY ACTION REGARDING THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. DURING THE CALL, THE PATIENT REPORTED THAT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THEY SUFFERED DKA (DIABETIC KETOACIDOSIS) BECAUSE THEY COULD NOT CHECK THEIR BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND WERE HOSPITALIZED. AT THE TIME OF TROUBLESHOOTING, THE PATIENT DECLINED TO PERFORM A TEST. THE ALLEGED ISSUE REMAINED UNRESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS THEY WE

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 24990787 ↗
• InjuryApr 24, 2026Device Alarm System

  ON (B)(6) 2026, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THEIR ONETOUCH ULTRA2 METER CONTINUED TO DISPLAY THE APPLY SAMPLE MESSAGE INSTEAD OF COUNTING DOWN AND PROVIDING A BLOOD GLUCOSE RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING, SINCE THE PATIENT DISCONNECTED THE CALL AND COULD NOT BE REACHED FOR FURTHER INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED METER ISSUE BEGAN 2 WEEKS AGO AROUND 8:00 AM TO 9:00 AM. THE PATIENT MANAGES THEIR DIABETES WITH LANTUS INSULIN (20-25 UNITS) AND HUMALOG INSULIN ON A SELF-ADJUSTING DOSE. THE PATIENT DID NOT REPORT TAKING ANY ACTION REGARDING THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. DURING THE CALL, THE PATIENT REPORTED THAT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THEY SUFFERED DKA (DIABETIC KETOACIDOSIS) BECAUSE THEY COULD NOT CHECK THEIR BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND WERE HOSPITALIZED. AT THE TIME OF TROUBLESHOOTING, THE PATIENT DECLINED TO PERFORM A TEST. THE ALLEGED ISSUE REMAINED UNRESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS THEY WE

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 24990780 ↗
• InjuryNov 6, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS REVERTING TO THE SET-UP MODE WHEN ATTEMPTING TO TEST HER BLOOD GLUCOSE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2025, BEFORE 12:00 PM, SHE BEGAN TO FEEL BAD AND ATTEMPTED TO TEST HER BLOOD GLUCOSE BUT WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING DUE TO THE REPORTED ISSUE. DESPITE THE ALLEGED ISSUE, THE PATIENT TOOK ACTION TO INCREASE HER GLUCOSE LEVEL BY EATING A CANDY BUT STARTED FEELING ¿VERY DIZZY, COLD AND BECAME UNCONSCIOUS¿ AT AROUND 12:00 PM. THE PATIENT REPORTED THAT AT AROUND 12:00 PM, SHE WAS TAKEN TO THE HOSPITAL BY AMBULANCE WHERE SHE WAS ADMITTED BECAUSE HER BLOOD GLUCOSE LEVEL WAS ¿TOO LOW¿ (NO SPECIFIC READING IN HOSPITAL WAS PROVIDED) AND SHE WAS IN "COMA". THE PATIENT STATED THAT SHE WAS ADMINISTERED INTRAVENOUS (IV) GLUCOSE AND THAT SHE STAYED IN HOSPITAL FOR 2-3 DAYS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA EDUCATED THE PATIENT ON THE CORRECT TESTING PROCEDURE AND WALKED THROUGH A TEST AND TH

  Patient problems: Alteration in Body Temperature; Coma; Dizziness; Hypoglycemia

  MAUDE report 23493380 ↗
• InjuryNov 6, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  ON NOVEMBER 04, 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH ULTRA 2 METER WAS REVERTING TO THE SET-UP MODE WHEN ATTEMPTING TO TEST HER BLOOD GLUCOSE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2025, BEFORE 12:00 PM, SHE BEGAN TO FEEL BAD AND ATTEMPTED TO TEST HER BLOOD GLUCOSE BUT WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING DUE TO THE REPORTED ISSUE. DESPITE THE ALLEGED ISSUE, THE PATIENT TOOK ACTION TO INCREASE HER GLUCOSE LEVEL BY EATING A CANDY BUT STARTED FEELING ¿VERY DIZZY, COLD AND BECAME UNCONSCIOUS¿ AT AROUND 12:00 PM. THE PATIENT REPORTED THAT AT AROUND 12;00 PM, SHE WAS TAKEN TO THE HOSPITAL BY AMBULANCE WHERE SHE WAS ADMITTED BECAUSE HER BLOOD GLUCOSE LEVEL WAS ¿TOO LOW¿ (NO SPECIFIC READING IN HOSPITAL WAS PROVIDED) AND SHE WAS IN "COMA". THE PATIENT STATED THAT SHE WAS ADMINISTERED INTRAVENOUS (IV) GLUCOSE AND THAT SHE STAYED IN HOSPITAL FOR 2-3 DAYS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA EDUCATED THE PATIENT ON THE CORRECT TESTING PROCEDURE AND WALKED THROUGH A TEST

  Patient problems: Alteration in Body Temperature; Coma; Dizziness; Hypoglycemia

  MAUDE report 23493379 ↗
• InjuryOct 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND COMPARED TO ANOTHER METER (UNSPECIFIED DOCTOR¿S METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE REPORTER DISCONTINUED THE INTERACTION COULD NOT BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE REPORTER INDICATED THAT THE PATIENT HAD JUST PURCHASED THE SYSTEM KIT 1 WEEK AGO AND ON AN UNSPECIFIED DATE OBTAINED HIGH BLOOD GLUCOSE RESULTS OF ¿585, 535 AND 600 MG/DL¿ WITH THE SUBJECT METER DURING A LOW BLOOD GLUCOSE EPISODE. IT WAS NOT REPORTED IF THE PATIENT TAKES ANY MEDICATION TO MANAGE THEIR DIABETES OR IF THEY TOOK ANY ACTION REGARDING THEIR USUAL DIABETES MANAGEMENT DUE TO THE REPORTED ISSUE. IT WAS NOT REPORTED WHAT SYMPTOMS THE PATIENT EXPERIENCED. HOWEVER, THE REPORTER CLAIMED THE PATIENT WENT TO AN EMERGENCY ROOM AS A RESULT OF THE ALLEGED ISSUE AND INDICATED THAT THE PATIENT RECEIVED A BLOOD GLUCOSE RESULT OF ¿51 MG/DL¿ ON THE DOCTOR¿S METER. THE TIME DIFFERENCE BETWEEN THE TESTS WAS NOT REPORTED. IT WAS NOT REPORTED WHAT TYPE O

  Patient problems: Hypoglycemia

  MAUDE report 23345699 ↗
• InjuryOct 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND COMPARED TO ANOTHER METER (UNSPECIFIED DOCTOR¿S METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE REPORTER DISCONTINUED THE INTERACTION COULD NOT BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE REPORTER INDICATED THAT THE PATIENT HAD JUST PURCHASED THE SYSTEM KIT 1 WEEK AGO AND ON AN UNSPECIFIED DATE OBTAINED HIGH BLOOD GLUCOSE RESULTS OF ¿585, 535 AND 600 MG/DL¿ WITH THE SUBJECT METER DURING A LOW BLOOD GLUCOSE EPISODE. IT WAS NOT REPORTED IF THE PATIENT TAKES ANY MEDICATION TO MANAGE THEIR DIABETES OR IF THEY TOOK ANY ACTION REGARDING THEIR USUAL DIABETES MANAGEMENT DUE TO THE REPORTED ISSUE. IT WAS NOT REPORTED WHAT SYMPTOMS THE PATIENT EXPERIENCED. HOWEVER, THE REPORTER CLAIMED THE PATIENT WENT TO AN EMERGENCY ROOM AS A RESULT OF THE ALLEGED ISSUE AND INDICATED THAT THE PATIENT RECEIVED A BLOOD GLUCOSE RESULT OF ¿51 MG/DL¿ ON THE DOCTOR¿S METER. THE TIME DIFFERENCE BETWEEN THE TESTS WAS NOT REPORTED. IT WAS NOT REPORTED WHAT TYPE O

  Patient problems: Hypoglycemia

  MAUDE report 23345696 ↗
• InjurySep 17, 2025Device Handling Problem; Device Handling Problem

  ON AUGUST 29, 2025, THE LAY USER/PATIENT¿S SPOUSE CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER READ INACCURATELY LOW WHEN COMPARED TO HER FEELINGS AND/OR NORMAL READINGS AND TO A HOSPITAL METER. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED WHEN THE MEDICAL SURVEILLANCE SPECIALIST REVIEWED THE CALL RECORDING. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY BEGAN ON AUGUST 22, 2025, AT 9:00 AM. THE REPORTER CLAIMED HE MEASURED THE PATIENT¿S BLOOD GLUCOSE WITH THE SUBJECT METER AND RECEIVED LOW BLOOD GLUCOSE READINGS OF ¿85 AND 230 MG/DL¿. THE REPORTER STATED THAT THE PATIENT¿S DIABETES IS MANAGED WITH ORAL MEDICATION (JANUVIA 100 MG, 1 PILL DAILY) AND THAT NO CHANGES WERE MADE TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER CLAIMED THAT ON AUGUST 22, 2025, AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT BECAME ¿PALE AND PASSED OUT¿. THE REPORTER STATED THAT HE CALLED EMERGENCY MEDICAL SERVICES, AND THAT THE PATIENT WAS TAKEN TO HOSPITAL BY AMBULANCE WHERE SHE RECEIVED A BLOOD GLUCOSE RESULT OF ¿OVER 400 MG/DL¿ ON ARRIVAL ON THE HOSPITAL METER. THE REPORTE

  Patient problems: Hyperglycemia; Pallor; Syncope/Fainting

  MAUDE report 23080543 ↗
• InjurySep 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS AND COMPARED TO OTHER METERS, AND COMPARED TO AN A1C RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN AROUND (B)(6) 2024. AT UNSPECIFIED TIMES, THE PATIENT REPORTED OBTAINING WHAT SHE FELT WERE INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿380, 387 AND 390 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT ALSO REPORTED OBTAINING A BLOOD GLUCOSE READING OF ¿387 MG/DL¿ WITH THE SUBJECT METER COMPARED TO A READING OF ¿114 MG/DL¿ ON A DOCTOR¿S METER, AND ALSO A READING OF ¿283 MG/DL¿ WITH THE SUBJECT METER COMPARED TO READINGS OF ¿112, 104 AND 91 MG/DL¿ ON A FREESTYLE LITE METER. FURTHERMORE, THE PATIENT REPORTED OBTAINING INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿380, 387, 390, 208 AND 238 MG/DL¿ WITH THE SUBJECT METER COMPARED TO AN A1C RESULT OF 5.2. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT WAS TAKING A COMBINATION OF DIABETES MEDICATIONS (METFORMIN AND OZEMPIC). BECAUSE HER READINGS WERE NOT GOING DO

  Patient problems: Abdominal Cramps; Diarrhea; Pancreatitis; Vomiting

  MAUDE report 22986870 ↗
• InjurySep 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS AND COMPARED TO OTHER METERS, AND COMPARED TO AN A1C RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN AROUND (B)(6) 2024. AT UNSPECIFIED TIMES, THE PATIENT REPORTED OBTAINING WHAT SHE FELT WERE INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿380, 387 AND 390 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT ALSO REPORTED OBTAINING A BLOOD GLUCOSE READING OF ¿387 MG/DL¿ WITH THE SUBJECT METER COMPARED TO A READING OF ¿114 MG/DL¿ ON A DOCTOR¿S METER, AND ALSO A READING OF ¿283 MG/DL¿ WITH THE SUBJECT METER COMPARED TO READINGS OF ¿112, 104 AND 91 MG/DL¿ ON A FREESTYLE LITE METER. FURTHERMORE, THE PATIENT REPORTED OBTAINING INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿380, 387, 390, 208 AND 238 MG/DL¿ WITH THE SUBJECT METER COMPARED TO AN A1C RESULT OF 5.2. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT WAS TAKING A COMBINATION OF DIABETES MEDICATIONS (METFORMIN AND OZEMPIC). BECAUSE HER READINGS WERE NOT GOING DO

  Patient problems: Abdominal Cramps; Diarrhea; Pancreatitis; Vomiting

  MAUDE report 22986867 ↗
• InjuryJul 17, 2025Device Alarm System; Device Alarm System

  ON (B)(6) 2025, THE LAY USER/PATIENT¿S SPOUSE CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER CONTINUED TO DISPLAY THE APPLY CONTROL MESSAGE INSTEAD OF COUNTING DOWN AND PROVIDING A CONTROL SOLUTION RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE REPORTER STATED THAT THE ALLEGED ISSUE BEGAN AROUND 2:00 PM-3:00 PM ON (B)(6) 2025. THE REPORTER DENIED THE PATIENT TOOK ANY ACTION REGARDING HIS USUAL DIABETES MANAGEMENT DUE TO THE ALLEGED ISSUE. THE REPORTER MENTIONED THAT AT AN UNSPECIFIED DATE AND TIME, THE PATIENT HAD ¿PASSED OUT AND WAS UNRESPONSIVE¿ AS A RESULT OF THE ALLEGED ISSUE AND WAS TREATED WITH GLUCOSE GEL BY EMERGENCY MEDICAL SERVICES. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA DETERMINED THE CORRECT STRIPS WERE BEING USED FOR TESTING AND THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CCA WALKED THROUGH RESOLVING THE ISSUE HOWEVER THE ISSUE COULD NOT BE RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING RE

  Patient problems: Loss of consciousness

  MAUDE report 22538470 ↗
• InjuryJul 17, 2025Device Alarm System; Device Alarm System

  ON (B)(6) 2025, THE LAY USER/PATIENT¿S SPOUSE CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER CONTINUED TO DISPLAY THE APPLY CONTROL MESSAGE INSTEAD OF COUNTING DOWN AND PROVIDING A CONTROL SOLUTION RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE REPORTER STATED THAT THE ALLEGED ISSUE BEGAN AROUND 2:00 PM-3:00 PM ON (B)(6) 2025 OR (B)(6) 2025. THE REPORTER DENIED THE PATIENT TOOK ANY ACTION REGARDING HIS USUAL DIABETES MANAGEMENT DUE TO THE ALLEGED ISSUE. THE REPORTER MENTIONED THAT AT AN UNSPECIFIED DATE AND TIME, THE PATIENT HAD ¿PASSED OUT AND WAS UNRESPONSIVE¿ AS A RESULT OF THE ALLEGED ISSUE AND WAS TREATED WITH GLUCOSE GEL BY EMERGENCY MEDICAL SERVICES. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA DETERMINED THE CORRECT STRIPS WERE BEING USED FOR TESTING AND THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CCA WALKED THROUGH RESOLVING THE ISSUE HOWEVER THE ISSUE COULD NOT BE RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLA

  Patient problems: Loss of consciousness

  MAUDE report 22538469 ↗
• InjuryJun 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH COMPARED TO THEIR FEELINGS/NORMAL RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN AT 02:00 PM ON (B)(6) 2025. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿201 MG/DL AND 193 MG/DL¿ WITH THE SUBJECT DEVICE WHICH THEY FELT WERE INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE PATIENT MANAGES THEIR DIABETES WITH SELF-ADJUSTED INSULIN (NPH INSULIN, 8 UNITS IN THE MORNING AND NOVOLIN R, 8 UNITS IN THE MORNING) AND THEY DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMENT IN RESPONSE TO THE ALLEGED ISSUE, REPORTING THAT THEY CONTINUED WITH THEIR USUAL ACTIVITIES. THE PATIENT REPORTED THAT AT AROUND 02:00 PM ON (B)(6) 2025 THAT THEY STARTED FEELING ¿CONFUSED¿, STATING THEY WERE ¿NOT PROCESSING EVERYTHING QUITE RIGHT¿ AND EXPERIENCED ¿TYPICAL LOW BLOOD SUGAR SYMPTOMS¿. THE PATIENT REPORTED THAT AN AMBULANCE WAS CALLED AND THAT THEY RECEIVED A GLUCOSE READING OF ¿48 MG/DL¿ ON A

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 22291618 ↗
• InjuryJun 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH COMPARED TO THEIR FEELINGS/NORMAL RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN AT 02:00 PM ON (B)(6) 2025. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿201 MG/DL AND 193 MG/DL¿ WITH THE SUBJECT DEVICE WHICH THEY FELT WERE INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE PATIENT MANAGES THEIR DIABETES WITH SELF-ADJUSTED INSULIN (NPH INSULIN, 8 UNITS IN THE MORNING AND NOVOLIN R, 8 UNITS IN THE MORNING) AND THEY DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMENT IN RESPONSE TO THE ALLEGED ISSUE, REPORTING THAT THEY CONTINUED WITH THEIR USUAL ACTIVITIES. THE PATIENT REPORTED THAT AT AROUND 02:00 PM ON (B)(6) 2025 THAT THEY STARTED FEELING ¿CONFUSED¿, STATING THEY WERE ¿NOT PROCESSING EVERYTHING QUITE RIGHT¿ AND EXPERIENCED ¿TYPICAL LOW BLOOD SUGAR SYMPTOMS¿. THE PATIENT REPORTED THAT AN AMBULANCE WAS CALLED AND THAT THEY RECEIVED A GLUCOSE READING OF ¿48 MG/DL¿ ON A

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 22289017 ↗
• InjuryJun 13, 2025Power Problem; Power Problem

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH ULTRA2 METER POWERS OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED DATE AND TIME IN (B)(6) 2025. THE PATIENT STATED THAT BECAUSE THEY WERE UNABLE TO OBTAIN BLOOD GLUCOSE READINGS, THEY STOPPED USING THE METER. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (JARDIANCE) WITH DIET AND/OR EXERCISE. THE PATIENT DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED EXPERIENCING SYMPTOMS OF FEELING ¿VERY LIGHTHEADED AND FALLING DOWN¿ FOR THE PAST MONTH, SINCE THE ALLEGED ISSUE BEGAN. DUE TO THE SYMPTOMS, THE PATIENT STATED THAT ON (B)(6) 2025, THEY WENT TO THE HOSPITAL WHERE THEY WERE FOUND TO HAVE "VERY HIGH BLOOD GLUCOSE LEVELS". THE PATIENT STATED THAT THEY WERE HOSPITALIZED FOR 3 DAYS AND ADMINISTERED INSULIN EACH DAY (DIFFERENT DOSES) TO LOWER THEIR GLUCOSE LEVELS. THE BLOOD GLUCOSE TEST RESULTS AT THE HOSPITAL WERE NOT PROVIDED. THE PATIENT WAS DISCHARGED ON (B)(6) 2025 AND ADVISED T

  Patient problems: Dizziness; Fall; Hyperglycemia

  MAUDE report 22207863 ↗
• InjuryJun 13, 2025Power Problem; Power Problem

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH ULTRA2 METER POWERS OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED DATE AND TIME IN (B)(6) 2025. THE PATIENT STATED THAT BECAUSE THEY WERE UNABLE TO OBTAIN BLOOD GLUCOSE READINGS, THEY STOPPED USING THE METER. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (JARDIANCE) WITH DIET AND/OR EXERCISE. THE PATIENT DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED EXPERIENCING SYMPTOMS OF FEELING ¿VERY LIGHTHEADED AND FALLING DOWN¿ FOR THE PAST MONTH, SINCE THE ALLEGED ISSUE BEGAN. DUE TO THE SYMPTOMS, THE PATIENT STATED THAT ON (B)(6) 2025, THEY WENT TO THE HOSPITAL WHERE THEY WERE FOUND TO HAVE "VERY HIGH BLOOD GLUCOSE LEVELS". THE PATIENT STATED THAT THEY WERE HOSPITALIZED FOR 3 DAYS AND ADMINISTERED INSULIN EACH DAY (DIFFERENT DOSES) TO LOWER THEIR GLUCOSE LEVELS. THE BLOOD GLUCOSE TEST RESULTS AT THE HOSPITAL WERE NOT PROVIDED. THE PATIENT WAS DISCHARGED ON (B)(6) 2025, AND ADVISED

  Patient problems: Dizziness; Fall; Hyperglycemia

  MAUDE report 22207862 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH COMPARED TO THEIR FEELINGS/NORMAL RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND BASED ON ADDITIONAL INFORMATION OBTAINED FROM LISTENING TO THE CALL RECORDING BY A CUSTOMER QUALITY SPECIALIST. THE REPORTER STATED THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED TIME ONE MONTH AGO, SOMETIME AROUND THE (B)(6) 2025. THE REPORTER CLAIMED THAT THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 325 MG/DL WITH THE SUBJECT DEVICE WHICH THEY FELT WAS INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE REPORTER DID NOT PROVIDE INFORMATION AROUND HOW THE PATIENT MANAGES THEIR DIABETES AND DENIED THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER STATED THAT THE PATIENT STARTED TO ¿FEEL REALLY DIZZY¿ AND AT AN UNSPECIFIED DATE/TIME AROUND THE (B)(6) 2025 THEY VISITED THE EMERGENCY ROOM. DURING THIS VISIT THE PATIENT RECEIVED A BLOOD GLUCOSE READING OF ¿63 MG/DL¿ ON AN UNSPECIFIED HOSPITAL METER AND HAD SOME FOOD AND AN O

  Patient problems: Dizziness

  MAUDE report 21869566 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH COMPARED TO THEIR FEELINGS/NORMAL RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND BASED ON ADDITIONAL INFORMATION OBTAINED FROM LISTENING TO THE CALL RECORDING BY A CUSTOMER QUALITY SPECIALIST. THE REPORTER STATED THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED TIME ONE MONTH AGO, SOMETIME AROUND THE (B)(6) 2025. THE REPORTER CLAIMED THAT THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 325 MG/DL WITH THE SUBJECT DEVICE WHICH THEY FELT WAS INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE REPORTER DID NOT PROVIDE INFORMATION AROUND HOW THE PATIENT MANAGES THEIR DIABETES AND DENIED THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER STATED THAT THE PATIENT STARTED TO ¿FEEL REALLY DIZZY¿ AND AT AN UNSPECIFIED DATE/TIME AROUND THE (B)(6) 2025 THEY VISITED THE EMERGENCY ROOM. DURING THIS VISIT THE PATIENT RECEIVED A BLOOD GLUCOSE READING OF ¿63 MG/DL¿ ON AN UNSPECIFIED HOSPITAL METER AND HAD SOME FOOD AND AN O

  Patient problems: Dizziness

  MAUDE report 21869565 ↗
• InjuryMar 31, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HIS ONETOUCH ULTRA2 METER DISPLAYED ERROR MESSAGES ¿ERROR 2, ERROR 4 AND ERROR 5¿ DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT SINCE HE GOT THE METER ON (B)(6) 2025, HE HAD BEEN UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE ERROR MESSAGES APPEARING. IT WAS NOT REPORTED IF THE PATIENT TAKES ANY MEDICATION TO MANAGE HIS DIABETES OR IF HE MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT MENTIONED THAT ON (B)(6) 2025, HE WENT TO THE HOSPITAL BECAUSE HE WAS ¿FEELING BAD¿ AND WAS GIVEN UNSPECIFIED MEDICATIONS. THE PATIENT DECLINED TO PROVIDE THE BLOOD GLUCOSE READINGS OBTAINED IN THE HOSPITAL. THE PATIENT REPORTED THAT HE STAYED IN HOSPITAL FOR 2 DAYS. AT THE TIME OF TROUBLESHOOTING, THE CCA WALKED THROUGH RESOLVING THE ISSUE HOWEVER THE ALLEGED ISSUE COULD NOT BE RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY REQUI

  Patient problems: Malaise

  MAUDE report 21735498 ↗
• InjuryMar 31, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HIS ONETOUCH ULTRA2 METER DISPLAYED ERROR MESSAGES ¿ERROR 2, ERROR 4 AND ERROR 5¿ DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT SINCE HE GOT THE METER ON (B)(6) 2025, HE HAD BEEN UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE ERROR MESSAGES APPEARING. IT WAS NOT REPORTED IF THE PATIENT TAKES ANY MEDICATION TO MANAGE HIS DIABETES OR IF HE MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT MENTIONED THAT ON (B)(6) 2025, HE WENT TO THE HOSPITAL BECAUSE HE WAS ¿FEELING BAD¿ AND WAS GIVEN UNSPECIFIED MEDICATIONS. THE PATIENT DECLINED TO PROVIDE THE BLOOD GLUCOSE READINGS OBTAINED IN THE HOSPITAL. THE PATIENT REPORTED THAT HE STAYED IN HOSPITAL FOR 2 DAYS. AT THE TIME OF TROUBLESHOOTING, THE CCA WALKED THROUGH RESOLVING THE ISSUE HOWEVER THE ALLEGED ISSUE COULD NOT BE RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY REQUI

  Patient problems: Malaise

  MAUDE report 21735497 ↗
• InjuryJan 15, 2025Device Alarm System; Device Alarm System

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH ULTRA2 METER CONTINUED TO DISPLAY THE APPLY SAMPLE MESSAGE INSTEAD OF COUNTING DOWN AND PROVIDING A BLOOD GLUCOSE RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2024, AT 5:30 AM AND SHE WAS UNABLE TO OBTAIN BLOOD GLUCOSE READINGS. PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT REPORTED THAT SHE BEGAN DEVELOPING SYMPTOMS DESCRIBED AS ¿HEADACHE, CANNOT SPEAK, CANNOT BREATHE, DIZZY, HIGH TEMPERATURE AND NO BLOOD GOING ON HER BODY¿ ON (B)(6) 2024, AT 5:30 AM. ON (B)(6) 2024, AT 7:00 AM, THE PATIENT REPORTED ATTENDING THE DOCTOR¿S OFFICE AND WAS HOSPITALIZED WITH A LOT OF SYMPTOMS WITH A BLOOD GLUCOSE VALUE OF ¿700 MG/DL¿. DURING THE FOLLOW-UP CALL, THE PATIENT DENIED RECEIVING A DIAGNOSIS ON HER CONDITION. THE PATIENT STATED THAT SHE STAYED IN HOSPITAL FOR 3 DAYS AND WAS TREATED WITH INJECTED MEDICATION FOR DIABETES BUT DID NOT RECALL THE NAME. DURING THE FOLLOWING UP CALL, THE PATIENT DENIED MAKING ANY CHANGES TO

  Patient problems: Alteration in Body Temperature; Dizziness; Dysphasia; Dyspnea; Headache; Hyperglycemia; Reduced Blood Flow

  MAUDE report 21156262 ↗
• InjuryJan 15, 2025Device Alarm System; Device Alarm System

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH ULTRA2 METER CONTINUED TO DISPLAY THE APPLY SAMPLE MESSAGE INSTEAD OF COUNTING DOWN AND PROVIDING A BLOOD GLUCOSE RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2024, AT 5:30 AM AND SHE WAS UNABLE TO OBTAIN BLOOD GLUCOSE READINGS. PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT REPORTED THAT SHE BEGAN DEVELOPING SYMPTOMS DESCRIBED AS ¿HEADACHE, CANNOT SPEAK, CANNOT BREATHE, DIZZY, HIGH TEMPERATURE AND NO BLOOD GOING ON HER BODY¿ ON (B)(6) 2024, AT 5:30 AM. ON (B)(6) 2024, AT 7:00 AM, THE PATIENT REPORTED ATTENDING THE DOCTOR¿S OFFICE AND WAS HOSPITALIZED WITH A LOT OF SYMPTOMS WITH A BLOOD GLUCOSE VALUE OF ¿700 MG/DL¿. DURING THE FOLLOW-UP CALL, THE PATIENT DENIED RECEIVING A DIAGNOSIS ON HER CONDITION. THE PATIENT STATED THAT SHE STAYED IN HOSPITAL FOR 3 DAYS AND WAS TREATED WITH INJECTED MEDICATION FOR DIABETES BUT DID NOT RECALL THE NAME. DURING THE FOLLOWING UP CALL, THE PATIENT DENIED MAKING ANY CHANGES TO

  Patient problems: Alteration in Body Temperature; Dizziness; Dysphasia; Dyspnea; Headache; Hyperglycemia; Reduced Blood Flow

  MAUDE report 21156261 ↗
• InjuryJan 14, 2025Power Problem; Power Problem

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HIS ONETOUCH ULTRA2 METER WOULD NOT POWER ON AND HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING, SINCE THE PATIENT DISCONNECTED THE CALL AND ATTEMPTS TO REACH THE PATIENT FOR FURTHER INFORMATION WERE UNSUCCESSFUL. IT WAS NOT REPORTED WHEN THE ALLEGED POWER ISSUE BEGAN. THE PATIENT STATED THAT THE METER WOULD NOT POWER ON DESPITE REPLACING THE BATTERY. DURING THE CALL, THE PATIENT MENTIONED THAT HE PURCHASED THE METER 2 MONTHS AGO. IT WAS NOT REPORTED HOW THE PATIENT MANAGES HIS TYPE 2 DIABETES, OR IF HE MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED ISSUE. DURING THE CALL, THE PATIENT REPORTED THAT ON AN UNSPECIFIED DATE, HE WAS HOSPITALIZED AND IN INTENSIVE CARE BECAUSE HIS BLOOD GLUCOSE ¿WENT HIGH¿ AND WAS UNABLE TO TEST HIS BLOOD GLUCOSE. NO FURTHER EVENT DETAILS WERE PROVIDED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT IS USING THE CORRECT BATTERY AND THERE W

  Patient problems: Diaphoresis; Hyperglycemia; Syncope/Fainting; Visual Impairment; Vomiting

  MAUDE report 21147681 ↗
• InjuryJan 14, 2025Power Problem; Power Problem

  ON (B)(6) 2025, THE PATIENT CONTACTED LFS AND PROVIDED ADDITIONAL EVENT INFORMATION. IT REMAINS UNCLEAR WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH ORAL MEDICATION (GLIMEPIRIDE AND METFORMIN) AND DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED ISSUE. THE PATIENT CLARIFIED THAT HE EXPERIENCED SYMPTOMS OF ¿SWEATING, COULD NOT SEE, THROWING UP AND PASSED OUT¿ (EXACT DATE UNCLEAR). THE PATIENT STATED THAT AN AMBULANCE WAS CALLED, AND THAT HE WAS TAKEN TO HOSPITAL WHERE HE RECEIVED A BLOOD GLUCOSE RESULT OF ¿687 MG/DL¿ ON THE HOSPITAL METER. THE PATIENT MENTIONED THAT HE WAS ADMITTED TO THE INTENSIVE CARE UNIT AND WAS TREATED WITH INSULIN, AND GLIMEPIRIDE AND METFORMIN MEDICATION. THE PATIENT STATED THAT HE WAS HOSPITALIZED FOR 10 DAYS AND THAT HE ATTRIBUTED THE REPORTED INJURY TO THE METER NOT TURNING ON.

  Patient problems: Diaphoresis; Hyperglycemia; Syncope/Fainting; Visual Impairment; Vomiting

  MAUDE report 21147675 ↗
• InjuryAug 18, 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), ALLEGING THAT THEIR ONETOUCH ULTRA2 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 AT 12:00 AM ON (B)(6) 2022. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿300 AND 350 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT REPORTED THAT THEY MANAGE THEIR DIABETES WITH A FIXED DOSE OF NOVORAPID INSULIN THREE TIMES A DAY BEFORE MEALS (20 UNITS BEFORE BREAKFAST, 25 UNITS BEFORE LUNCH AND 20 UNITS BEFORE DINNER). IN RESPONSE TO THE ELEVATED READINGS, THE PATIENT REPORTED ADMINISTERING THEIR USUAL BEFORE DINNER DOSE OF INSULIN (20 UNITS) THEN STARTED TO FEEL SYMPTOMS OF ¿TIRED, HYPO AND SWEATING¿. THE PATIENT CLAIMED THEY CONSUMED FOOD IN RESPONSE TO THEIR SYMPTOMS BETWEEN 12:15 AM AND 12:20 AM THAT MORNING. THE PATIENT DENIED THAT THEIR BLOOD GLUCOSE WAS TESTED WITH ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THE CORRECT TESTING PROCESS WAS

  Patient problems: Diaphoresis; Fatigue; Hypoglycemia

  MAUDE report 15255533 ↗
• InjuryAug 18, 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), ALLEGING THAT THEIR ONETOUCH ULTRA2 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 AT 12:00 AM ON (B)(6) 2022. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿300 AND 350 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT REPORTED THAT THEY MANAGE THEIR DIABETES WITH A FIXED DOSE OF NOVORAPID INSULIN THREE TIMES A DAY BEFORE MEALS (20 UNITS BEFORE BREAKFAST, 25 UNITS BEFORE LUNCH AND 20 UNITS BEFORE DINNER). IN RESPONSE TO THE ELEVATED READINGS, THE PATIENT REPORTED ADMINISTERING THEIR USUAL BEFORE DINNER DOSE OF INSULIN (20 UNITS) THEN STARTED TO FEEL SYMPTOMS OF ¿TIRED, HYPO AND SWEATING¿. THE PATIENT CLAIMED THEY CONSUMED FOOD IN RESPONSE TO THEIR SYMPTOMS BETWEEN 12:15 AM AND 12:20 AM THAT MORNING. THE PATIENT DENIED THAT THEIR BLOOD GLUCOSE WAS TESTED WITH ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THE CORRECT TESTING PROCESS WAS

  Patient problems: Diaphoresis; Fatigue; Hypoglycemia

  MAUDE report 15255410 ↗