OneTouch Verio Flex 023-194Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00353885010719), received between Feb 2, 2017 and Jul 26, 2023 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Power Problem” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2023Power Problem; Power Problem

  ON JULY 24, 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT HER ONETOUCH VERIO FLEX METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE BEGAN 3 WEEKS PRIOR TO CONTACTING LFS, AND SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION (JANUMET 50/500 MG, 2 TABLETS DAILY). 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 ON (B)(6) 2023, SHE DEVELOPED SYMPTOMS OF FEELING ¿LIGHTHEADED¿ AND FEELING ¿LIKE FALLING DOWN¿. THE PATIENT REPORTED THAT SHE DRANK WATER AND CONSUMED CANDY AS SELF-TREATMENT FOR THE SYMPTOMS. THE PATIENT DENIED USING ANY OTHER DEVICE TO TEST HER BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THERE WAS NO INDICATION OF MISUSE. THE CCA NOTED THE BATTERY NEEDED TO BE REPLACED, HOWEVER THE ISSUE WAS NOT RESOLVED AFTER A NEW BATTERY WAS INSTALLED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAI

  Patient problems: Dizziness

  MAUDE report 17401818 ↗
• InjuryJul 26, 2023Power Problem; Power Problem

  ON (B)(6) 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT HER ONETOUCH VERIO FLEX METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE BEGAN 3 WEEKS PRIOR TO CONTACTING LFS, AND SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION (JANUMET 50/500 MG, 2 TABLETS DAILY). 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 ON (B)(6) 2023, SHE DEVELOPED SYMPTOMS OF FEELING ¿LIGHTHEADED¿ AND FEELING ¿LIKE FALLING DOWN¿. THE PATIENT REPORTED THAT SHE DRANK WATER AND CONSUMED CANDY AS SELF-TREATMENT FOR THE SYMPTOMS. THE PATIENT DENIED USING ANY OTHER DEVICE TO TEST HER BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THERE WAS NO INDICATION OF MISUSE. THE CCA NOTED THE BATTERY NEEDED TO BE REPLACED, HOWEVER THE ISSUE WAS NOT RESOLVED AFTER A NEW BATTERY WAS INSTALLED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT

  Patient problems: Dizziness

  MAUDE report 17401815 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE LAY-USER/PATIENT¿S SPOUSE CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER READ INACCURATE. 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 (EXACT TIME NOT REPORTED). THE REPORTER CLAIMED THE PATIENT OBTAINED AN ALLEGED INACCURATE RESULT OF ¿8.5 MMOL/L¿ WITH THE SUBJECT METER. THIS WAS REPORTEDLY A NORMAL RESULT FOR THE PATIENT. THE REPORTER INFORMED THE CSA THAT THE PATIENT MANAGES HIS DIABETES WITH A FIXED DOSE OF INSULIN (TYPE/DOSE NOT REPORTED) AND DENIED THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURATE RESULT. THE REPORTER CLAIMED THAT ON (B)(6) 2020 AT 4:25 PM, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT STARTED DEVELOPING SYMPTOMS OF ¿SWEATING PROFUSELY, FEELING THE BODY WITH A SENSATION OF OVERHEAT, HIS EYES ROLLED TO THE BACK OF HIS HEAD AND WAS UNABLE TO SPEAK.¿ THE REPORTER CLAIMED SHE PROCEEDED TO CONTACT THE EMERGENCY MEDICAL SERVICE (EMS) FOR ASSISTANCE AND WHEN THEY ARRIVED AT 4:51 PM, THE PATIENT¿S BLOOD GLUCOSE TESTED ¿2.1 MMOL/L¿ ON THE EM

  Patient problems: Alteration In Body Temperature; Dysphasia; Sweating

  MAUDE report 10104818 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE LAY-USER/PATIENT¿S SPOUSE CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER READ INACCURATE. 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 (EXACT TIME NOT REPORTED). THE REPORTER CLAIMED THE PATIENT OBTAINED AN ALLEGED INACCURATE RESULT OF ¿8.5 MMOL/L¿ WITH THE SUBJECT METER. THIS WAS REPORTEDLY A NORMAL RESULT FOR THE PATIENT. THE REPORTER INFORMED THE CSA THAT THE PATIENT MANAGES HIS DIABETES WITH A FIXED DOSE OF INSULIN (TYPE/DOSE NOT REPORTED) AND DENIED THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURATE RESULT. THE REPORTER CLAIMED THAT ON (B)(6) 2020 AT 4:25 PM, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT STARTED DEVELOPING SYMPTOMS OF ¿SWEATING PROFUSELY, FEELING THE BODY WITH A SENSATION OF OVERHEAT, HIS EYES ROLLED TO THE BACK OF HIS HEAD AND WAS UNABLE TO SPEAK.¿ THE REPORTER CLAIMED SHE PROCEEDED TO CONTACT THE EMERGENCY MEDICAL SERVICE (EMS) FOR ASSISTANCE AND WHEN THEY ARRIVED AT 4:51 PM, THE PATIENT¿S BLOOD GLUCOSE TESTED ¿2.1 MMOL/L¿ ON THE EM

  Patient problems: Alteration In Body Temperature; Dysphasia; Sweating

  MAUDE report 10104817 ↗
• MalfunctionMar 16, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER READ INACCURATELY ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿201 AND 267 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR PRECISION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8427113 ↗
• MalfunctionApr 11, 2017Low Battery; Low Battery

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING BATTERY INDICATOR. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6479389 ↗
• MalfunctionMar 21, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING ERROR 4. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6419919 ↗
• MalfunctionFeb 25, 2017Incomplete or Missing Packaging; Incomplete or Missing Packaging

  ON (B)(6) /2017 THE REPORTER CONTACTED LIFESCAN USA, ALLEGING LANCETS MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6359410 ↗
• MalfunctionFeb 2, 2017Defective Device; Defective Device

  ON 01/25/2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING DAMAGED PACKAGING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6295612 ↗