OneTouch Verio 022-899Recalls & reported problems
LifeScan Europe GmbH · OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters · Class 2
All models of OneTouch Verio (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
These are OneTouch Verio blood glucose test strips used for self-testing with OneTouch Verio meters. The 63 reports describe strips that would not go into the meter, bent or poorly cut strips, strips missing from the vial, and meters failing to draw a blood sample. All63 were malfunctions with no injuries and no deaths, and none affected patients. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 63
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00353885009768), received between Nov 25, 2016 and Nov 30, 2018 — classified as 63 malfunctions.
The most frequently reported specific device problem is “Defective Device” (11 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
Device problems
- Appropriate Device Problem Term/Code Not Available13
- Defective Device11
- Sticking11
- Failure to Obtain Sample7
- Bent6
- Off-Label Use6
- Defective Component3
- Device Displays Incorrect Message3
Patient problems
- No Consequences Or Impact To Patient63
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2018Defective Component; Defective Component
DEVICE EVALUATION: THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS FAILED TESTING; THE REPORTED ISSUE WAS CONFIRMED. THE TEST STRIPS VIAL WAS FOUND TO BE OPEN. COMPLAINTS RELATING TO THE REPORTED PRODUCT WERE EVALUATED. IT WAS CONCLUDED THAT THE NUMBER OF COMPLAINTS FOR THE PRODUCT DID NOT BREACH THRESHOLDS INDICATIVE OF A SYSTEMIC ISSUE. ON 09/04/2018, THE LAY USER/PATIENT CONTACTED LIFESCAN USA, ALLEGING THAT THEIR OT VERIO VIAL WAS OPEN BEFORE THE FIRST TIME USE. THIS COMPLAINT WAS INITIALLY RULED OUT BECAUSE DURING CUSTOMER SERVICES TROUBLESHOOTING, THERE WAS NO INDICATION TO REASONABLY SUGGEST THAT THE PRODUCT MALFUNCTIONED AND THERE WAS ALSO NO ALLEGATION OF AN ADVERSE EVENT AS A RESULT OF THE REPORTED ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8119082 ↗MalfunctionJul 27, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DEVICE EVALUATION: THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. TEST STRIPS WERE FOUND TO HAVE BEEN MIS-CUT DURING THE SINGULTATION PROCESS. COMPLAINTS RELATING TO THE REPORTED PRODUCT WERE EVALUATED. IT WAS CONCLUDED THAT THE NUMBER OF COMPLAINTS FOR THE PRODUCT DID NOT BREACH THRESHOLDS INDICATIVE OF A SYSTEMIC ISSUE. ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (B)(6), ALLEGING THAT THEIR OT VERIO TEST STRIPS WERE MIS-CUT. THIS COMPLAINT WAS INITIALLY RULED OUT BECAUSE DURING CUSTOMER SERVICES TROUBLESHOOTING, THERE WAS NO INDICATION TO REASONABLY SUGGEST THAT THE PRODUCT MALFUNCTIONED AND THERE WAS ALSO NO ALLEGATION OF AN ADVERSE EVENT AS A RESULT OF THE REPORTED ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7725422 ↗MalfunctionMay 5, 2017Sticking; Sticking
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING STICKING TEST STRIP. 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 6546838 ↗MalfunctionMay 3, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING STRIP CUT ISSUE. 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 6539591 ↗MalfunctionMay 3, 2017Off-Label Use; Off-Label Use
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING TEST STRIPS 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 6539580 ↗MalfunctionMay 3, 2017Bent; Bent
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING BENT TEST STRIP. 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 6539537 ↗MalfunctionMay 2, 2017Failure to Obtain Sample; Failure to Obtain Sample
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING SAMPLE DRAW ISSUE. 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 6536236 ↗MalfunctionMay 2, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING STRIP CUT ISSUE. 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 6536101 ↗MalfunctionMay 1, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING STRIP ISSUE. 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 6533273 ↗MalfunctionMay 1, 2017Defective Component; Defective Component
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING OPEN VIAL. 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 6533270 ↗MalfunctionApr 25, 2017Sticking; Sticking
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING STICKING TEST STRIP. 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 6517838 ↗MalfunctionApr 25, 2017Sticking; Sticking
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING STICKING TEST STRIP. 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 6517792 ↗MalfunctionApr 25, 2017Bent; Bent
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING BENT TEST STRIP. 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 6517791 ↗MalfunctionApr 19, 2017Defective Component; Defective Component
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING OPEN VIAL. 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 6502747 ↗MalfunctionApr 15, 2017Sticking; Sticking
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING STICKING TEST STRIP. 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 6495926 ↗MalfunctionApr 15, 2017Bent; Bent
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING BENT TEST STRIP. 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 6495921 ↗MalfunctionApr 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING STRIP ISSUE. 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 6479417 ↗MalfunctionApr 6, 2017Sticking; Sticking
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING STICKING TEST STRIP. 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 6463030 ↗MalfunctionApr 4, 2017Bent; Bent
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING BENT TEST STRIP. 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 6455993 ↗MalfunctionMar 30, 2017Failure to Obtain Sample; Failure to Obtain Sample
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING SAMPLE DRAW ISSUE. 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 6445330 ↗MalfunctionMar 21, 2017Unsealed Device Packaging; Unsealed Device Packaging
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING CLOSURE SEAL ISSUE. 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 6419968 ↗MalfunctionMar 20, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING STRIP ISSUE. 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 6416534 ↗MalfunctionMar 17, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING STRIP ISSUE. 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 6412455 ↗MalfunctionMar 9, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING SAMPLE NOT DRAWN IN. 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 6390544 ↗MalfunctionFeb 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING STRIP CUT ISSUE. 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 6344900 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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