OneTouch Verio Flex 024044Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00353885011839), received between Feb 19, 2025 and Sep 29, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Device Displays Incorrect Message

  Patient problems: Fatigue; Hypoglycemia; Loss of consciousness

  MAUDE report 50926761 ↗
• InjurySep 29, 2026Device Displays Incorrect Message

  Patient problems: Fatigue; Hypoglycemia; Loss of consciousness

  MAUDE report 50926758 ↗
• InjuryAug 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  On (b)(6) 2026, the patient contacted LifeScan (LFS), alleging that their OneTouch Verio Flex meter read inaccurately high compared to another meter. 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. It was not reported when the alleged meter inaccuracy began. The patient claimed obtaining a blood glucose reading of ¿161 mg/dL¿ with the subject meter compared to an unspecified reading on another OneTouch meter. It was not reported if the patient took any action regarding their usual diabetes management as a result of the alleged issue. The patient reported that they were hospitalized for a week because their ¿sugar dropped¿, claiming the subject meter was displaying high readings when they were low. No further event details were provided. It was not reported what treatment the patient received.At the time of troubleshooting, the CCA noted the test strip vial was intact, and the test strips had been stored correctly and were not expired or opened past their discard date. The CCA noted the patient did not have control solution available to perform a quality control test. T

  Patient problems: Hypoglycemia

  MAUDE report 50360201 ↗
• InjuryNov 4, 2025Power Problem; Power Problem

  ON (B)(6) 2025, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER WOULD TURN OFF DURING USE AND NO LONGER TURNS ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED POWER ISSUE BEGAN 3 MONTHS AGO. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN 1000 MG) AND INSULIN (NOVOLOG/DOSE UNSPECIFIED). THE REPORTER DENIED THE PATIENT MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER STATED THAT ON (B)(6) 2025, AT 2:00 AM, THE PATIENT BECAME ¿UNCONSCIOUS¿ AND WAS TREATED BY EMERGENCY MEDICAL SERVICES (EMS) WITH IV GLUCOSE AND AN UNSPECIFIED INJECTION. PRIOR TO RECEIVING TREATMENT, THE REPORTER CLAIMED THAT THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED ON THE EMS METER AND A RESULT OF ¿43 MG/DL¿ WAS OBTAINED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THAT THERE WAS NO INDICATION OF MISUSE OF THE DEVICE. THE CCA NOTED THAT THE METER WOULD NOT POWER ON MANUALLY WHEN THE POWER BUTTON WAS PRESSED OR WHEN A TEST

  Patient problems: Hypoglycemia; Syncope/Fainting

  MAUDE report 23472442 ↗
• InjuryNov 4, 2025Power Problem; Power Problem

  ON OCTOBER 27, 2025, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER WOULD TURN OFF DURING USE AND NO LONGER TURNS ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED POWER ISSUE BEGAN 3 MONTHS AGO. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN 1000 MG) AND INSULIN (NOVOLOG/DOSE UNSPECIFIED). THE REPORTER DENIED THE PATIENT MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER STATED THAT ON (B)(6) 2025, AT 2:00 AM, THE PATIENT BECAME ¿UNCONSCIOUS¿ AND WAS TREATED BY EMERGENCY MEDICAL SERVICES (EMS) WITH IV GLUCOSE AND AN UNSPECIFIED INJECTION. PRIOR TO RECEIVING TREATMENT, THE REPORTER CLAIMED THAT THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED ON THE EMS METER AND A RESULT OF ¿43 MG/DL¿ WAS OBTAINED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THAT THERE WAS NO INDICATION OF MISUSE OF THE DEVICE. THE CCA NOTED THAT THE METER WOULD NOT POWER ON MANUALLY WHEN THE POWER BUTTON WAS PRESSED OR WHEN A

  Patient problems: Hypoglycemia; Syncope/Fainting

  MAUDE report 23472441 ↗
• InjurySep 4, 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 VERIO FLEX METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS AND COMPARED TO ANOTHER METER (RELION), AND TO A CONTINUOUS GLUCOSE MONITORING (CGM) DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON THE MORNING OF (B)(6) 2025, AT AROUND 10:00 AM. THE PATIENT REPORTED OBTAINING WHAT SHE FELT WAS AN INACCURATE HIGH BLOOD GLUCOSE READING OF ¿197 MG/DL¿ WITH THE SUBJECT METER AND COMPARED THE METER READING TO AN UNSPECIFIED READING OBTAINED ON HER OTHER METER THEN TO A READING OF ¿137 MG/DL¿ OBTAINED ON HER CGM DEVICE. THE PATIENT MANAGES HER DIABETES WITH INSULIN LISPRO ON A SELF-ADJUSTING DOSE. THE PATIENT STATED THAT BASED ON THE HIGH READING OF ¿197 MG/DL¿, SHE TOOK AN INCREASED DOSE OF INSULIN ACCORDING TO HER DOCTOR¿S RECOMMENDATION. 1 HOUR LATER, THE PATIENT REPORTED HAVING A LOW BLOOD GLUCOSE EPISODE WITH SYMPTOMS OF ¿FEELING BAD, SWEATY, DIZZY AND LIKE PASSING OUT¿. THE PATIENT REPORTED TREATING HERSELF USING BAQSIMI (GLUCAGON NASAL SPRAY) TO RAISE

  Patient problems: Diaphoresis; Dizziness; Hypoglycemia; Malaise; Presyncope

  MAUDE report 22974290 ↗
• InjurySep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON AUGUST 27, 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO FLEX METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS AND COMPARED TO ANOTHER METER (RELION), AND TO A CONTINUOUS GLUCOSE MONITORING (CGM) DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON THE MORNING OF (B)(6) 2025, AT AROUND 10:00 AM. THE PATIENT REPORTED OBTAINING WHAT SHE FELT WAS AN INACCURATE HIGH BLOOD GLUCOSE READING OF ¿197 MG/DL¿ WITH THE SUBJECT METER AND COMPARED THE METER READING TO AN UNSPECIFIED READING OBTAINED ON HER OTHER METER THEN TO A READING OF ¿137 MG/DL¿ OBTAINED ON HER CGM DEVICE. THE PATIENT MANAGES HER DIABETES WITH INSULIN LISPRO ON A SELF-ADJUSTING DOSE. THE PATIENT STATED THAT BASED ON THE HIGH READING OF ¿197 MG/DL¿, SHE TOOK AN INCREASED DOSE OF INSULIN ACCORDING TO HER DOCTOR¿S RECOMMENDATION. 1 HOUR LATER, THE PATIENT REPORTED HAVING A LOW BLOOD GLUCOSE EPISODE WITH SYMPTOMS OF ¿FEELING BAD, SWEATY, DIZZY AND LIKE PASSING OUT¿. THE PATIENT REPORTED TREATING HERSELF USING BAQSIMI (GLUCAGON NASAL SPRAY) TO R

  Patient problems: Diaphoresis; Dizziness; Hypoglycemia; Malaise; Presyncope

  MAUDE report 22974289 ↗
• InjuryMar 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) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO FLEX METER READ INACCURATELY HIGH COMPARED HER FEELINGS AND/OR NORMAL READINGS. 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. THE PATIENT REPORTED THAT ON (B)(6) 2025, AT 8:07 PM, SHE OBTAINED A BLOOD GLUCOSE READING OF ¿107 MG/DL¿ WITH THE SUBJECT METER DURING A HYPOGLYCEMIC EVENT. THE PATIENT REPORTED EXPERIENCING SYMPTOMS OF ¿SHAKING, WEAKNESS, FATIGUE, CONFUSION AND NAUSEA¿. THE PATIENT STATED THAT AN AMBULANCE WAS CALLED AND WHEN THE AMBULANCE ARRIVED, SHE RECEIVED A BLOOD GLUCOSE RESULT OF ¿63 MG/DL¿ ON THE AMBULANCE METER AT 8:20 PM. DURING THE CALL, THE PATIENT STATED THAT SHE WAS TREATED WITH SALINE AND GIVEN SOMETHING SWEET TO DRINK AND WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). THE TREATMENT PROVIDED AT THE ER WAS NOT PROVIDED. DURING THE CALL, THE PATIENT MENTIONED THAT SHE HAS BRITTLE DIABETES AND HAS HYPOGLYCEMIA EVERY OTHER DAY. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET

  Patient problems: Confusion/ Disorientation; Fatigue; Nausea; Shaking/Tremors

  MAUDE report 21649464 ↗
• InjuryMar 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON MARCH 06, 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO FLEX METER READ INACCURATELY HIGH COMPARED HER FEELINGS AND/OR NORMAL READINGS. 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. THE PATIENT REPORTED THAT ON (B)(6) 2025, AT 8:07 PM, SHE OBTAINED A BLOOD GLUCOSE READING OF ¿107 MG/DL¿ WITH THE SUBJECT METER DURING A HYPOGLYCEMIC EVENT. THE PATIENT REPORTED EXPERIENCING SYMPTOMS OF ¿SHAKING, WEAKNESS, FATIGUE, CONFUSION AND NAUSEA¿. THE PATIENT STATED THAT AN AMBULANCE WAS CALLED AND WHEN THE AMBULANCE ARRIVED, SHE RECEIVED A BLOOD GLUCOSE RESULT OF ¿63 MG/DL¿ ON THE AMBULANCE METER AT 8:20 PM. DURING THE CALL, THE PATIENT STATED THAT SHE WAS TREATED WITH SALINE AND GIVEN SOMETHING SWEET TO DRINK AND WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). THE TREATMENT PROVIDED AT THE ER WAS NOT PROVIDED. DURING THE CALL, THE PATIENT MENTIONED THAT SHE HAS BRITTLE DIABETES AND HAS HYPOGLYCEMIA EVERY OTHER DAY. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS

  Patient problems: Confusion/ Disorientation; Fatigue; Nausea; Shaking/Tremors

  MAUDE report 21649463 ↗
• InjuryFeb 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON JANUARY 24, 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HIS ONETOUCH VERIO FLEX METER READ INACCURATELY LOW COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. 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. THE PATIENT REPORTED THAT ON (B)(6) 2025, AT AROUND 3:30 PM, HE BEGAN FEELING ¿LIGHTHEADED AND DIZZY¿. THE PATIENT CLAIMED HE TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER AT AROUND 4:00 PM AND OBTAINED AN ALLEGED INACCURATE LOW BLOOD GLUCOSE READING OF ¿300 MG/DL¿. THE PATIENT STATED THAT HE PROCEEDED TO THE EMERGENCY ROOM (ER) WHERE HE RECEIVED A BLOOD GLUCOSE RESULT OF ¿500 MG/DL¿ ON THE ER METER AT AROUND 4:30 PM AND RECEIVED UNSPECIFIED TREATMENT INTRAVENOUSLY AND 1 PILL OF METFORMIN 500 MG. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE CCA NOTED THE PATIENT DID NOT HAVE CONTROL

  Patient problems: Dizziness; Hyperglycemia

  MAUDE report 21411315 ↗
• InjuryFeb 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) UNITED STATES, ALLEGING THAT HIS ONETOUCH VERIO FLEX METER READ INACCURATELY LOW COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. 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. THE PATIENT REPORTED THAT ON (B)(6) 2025, AT AROUND 3:30 PM, HE BEGAN FEELING ¿LIGHTHEADED AND DIZZY¿. THE PATIENT CLAIMED HE TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER AT AROUND 4:00 PM AND OBTAINED AN ALLEGED INACCURATE LOW BLOOD GLUCOSE READING OF ¿300 MG/DL¿. THE PATIENT STATED THAT HE PROCEEDED TO THE EMERGENCY ROOM (ER) WHERE HE RECEIVED A BLOOD GLUCOSE RESULT OF ¿500 MG/DL¿ ON THE ER METER AT AROUND 4:30 PM AND RECEIVED UNSPECIFIED TREATMENT INTRAVENOUSLY AND 1 PILL OF METFORMIN 500 MG. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE CCA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUT

  Patient problems: Dizziness; Hyperglycemia

  MAUDE report 21411310 ↗