OneTouch Verio Flex 023-270Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00353885010979), received between Dec 23, 2016 and Oct 15, 2025 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Device Handling Problem; Device Handling Problem

  ON (B)(6) 2025, THE SPOUSE OF A LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA. THE REPORTER ALLEGED THAT THE PATIENT RECEIVED AN INACCURATE HIGH CONTROL SOLUTION RESULT IN ADDITION TO ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER WAS GENERATING INACCURATELY HIGH RESULTS COMPARED TO HIS FEELING/NORMAL RESULTS AND COMPARED TO HIS CONTINUOUS GLUCOSE MONITOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED ISSUE BEGAN ALMOST TWO MONTHS PRIOR, AT AN UNSPECIFIED DATE. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED A GLUCOSE READING OF 249 MG/DL, WHICH WAS CONSIDERED UNUSUALLY HIGH FOR HIM COMPARED TO HIS FEELING/NORMAL RESULTS AND WITHIN 2 MINUTES WAS COMPARED TO HIS DEXCOM CONTINUOUS GLUCOSE MONITOR GLUCOSE READING OF 110 MG/DL. IN ADDITION TO THIS, THE REPORTER ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED AN INACCURATE HIGH CONTROL SOLUTION RESULT OF 404MG/DL. THE PATIENT MANAGES THEIR DIABETES WITH THE FOLLOWING MEDICATION: LANTUS - 26 UNITS, SHORT-ACTING INSULIN 12 UNITS BEFORE EVERY MEAL, METFORMIN TWO TABLETS OF UNSPECIFIED DOSAGE. THE PATIENT DID NOT MAKE ANY CHANGES TO THEIR MEDICATION IN RESPONSE

  Patient problems: Syncope/Fainting

  MAUDE report 23299946 ↗
• InjuryOct 15, 2025Device Handling Problem; Device Handling Problem

  ON (B)(6) 2025, THE SPOUSE OF A LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA. THE REPORTER ALLEGED THAT THE PATIENT RECEIVED AN INACCURATE HIGH CONTROL SOLUTION RESULT IN ADDITION TO ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER WAS GENERATING INACCURATELY HIGH RESULTS COMPARED TO HIS FEELING/NORMAL RESULTS AND COMPARED TO HIS CONTINUOUS GLUCOSE MONITOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED ISSUE BEGAN ALMOST TWO MONTHS PRIOR, AT AN UNSPECIFIED DATE. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED A GLUCOSE READING OF 249 MG/DL, WHICH WAS CONSIDERED UNUSUALLY HIGH FOR HIM COMPARED TO HIS FEELING/NORMAL RESULTS AND WITHIN 2 MINUTES WAS COMPARED TO HIS DEXCOM CONTINUOUS GLUCOSE MONITOR GLUCOSE READING OF 110 MG/DL. IN ADDITION TO THIS, THE REPORTER ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED AN INACCURATE HIGH CONTROL SOLUTION RESULT OF 404MG/DL. THE PATIENT MANAGES THEIR DIABETES WITH THE FOLLOWING MEDICATION: LANTUS - 26 UNITS, SHORT-ACTING INSULIN 12 UNITS BEFORE EVERY MEAL, METFORMIN TWO TABLETS OF UNSPECIFIED DOSAGE. THE PATIENT DID NOT MAKE ANY CHANGES TO THEIR MEDICATION IN RESPONSE

  Patient problems: Syncope/Fainting

  MAUDE report 23286844 ↗
• MalfunctionMar 7, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ON (B)(6) 2018, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER READ INACCURATELY ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿300 AND 88 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 7319660 ↗
• MalfunctionApr 2, 2017Loss of Power; Loss of Power

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING UNIT POWERS OFF DURING USE. 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 6452215 ↗
• MalfunctionFeb 23, 2017Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING ILLEGIBLE INFO - LITERATURE. 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 6352085 ↗
• MalfunctionFeb 17, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING LITERATURE 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 6338402 ↗
• MalfunctionFeb 16, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING LITERATURE 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 6334944 ↗
• MalfunctionJan 19, 2017Loss of Power; Loss of Power

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING DOES NOT TURN ON - METER. 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 6262923 ↗
• MalfunctionJan 16, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THERE WAS LITERATURE MISSING FROM THE PACKAGING OF THE SUBJECT METER. 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 6253003 ↗
• MalfunctionJan 16, 2017Off-Label Use; Off-Label Use

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING REDIRECTED PRODUCT. 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 6252972 ↗
• MalfunctionJan 6, 2017Loss of Power; Loss of Power

  ON (B)(6) 2016, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING UNIT POWERS OFF DURING USE. 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 6228027 ↗
• MalfunctionJan 5, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ON (B)(6) 2016, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (CONTOUR). THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿241 AND 223 MG/DL¿ WITH THE SUBJECT METER AND ¿160 MG/DL¿ ON ANOTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. 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 6224432 ↗
• MalfunctionDec 23, 2016Device Alarm System; Device Alarm System

  ON (B)(6) 2016, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING APPLY SAMPLE - METER. 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 6201786 ↗
• MalfunctionDec 23, 2016Device Alarm System; Device Alarm System

  ON (B)(6) 2016, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING APPLY SAMPLE. 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 6201771 ↗