OneTouch Verio 022-898Recalls & 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
This LifeScan OneTouch Verio test strip is used with a blood glucose meter for self-testing. Its 78 reports, with no deaths and 1 injury, mostly describe malfunctions (77 reports): strips sticking together, blood samples not being drawn in, and damaged vials. Most reports say no patient was affected. 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
- 78
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00353885009751), received between Nov 26, 2016 and Nov 22, 2018 — classified as 1 injury, 77 malfunctions.
The most frequently reported specific device problem is “Sticking” (25 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
- Sticking25
- Appropriate Device Problem Term/Code Not Available17
- Failure to Obtain Sample8
- Off-Label Use8
- Bent7
- Defective Component4
- Component Missing1
- Contamination1
Patient problems
- No Consequences Or Impact To Patient77
- Blurred Vision1
- Shaking/Tremors1
Recent adverse event reports
The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2018Defective Component; Defective Component
DEVICE EVALUATION: THE LAY USER/PATIENTS TEST STRIP VIAL HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE VIAL FAILED TESTING; THE REPORTED ISSUE WAS CONFIRMED. THE VIAL WAS FOUND TO BE DAMAGED. 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 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 8098373 ↗MalfunctionNov 15, 2018Physical Resistance/Sticking; Physical Resistance/Sticking
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 WERE FOUND TO BE STICKING TOGETHER DUE TO STATIC OR SMALL AMOUNTS OF ADHESIVE. COMPLAINTS RELATING TO THE REPORTED PRODUCT WAS 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 USA, ALLEGING THAT THEIR OT VERIO TEST STRIPS WERE STICKING TOGETHER. 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 8072825 ↗MalfunctionMay 6, 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 6549983 ↗MalfunctionMay 5, 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 6546753 ↗MalfunctionMay 2, 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 6536209 ↗MalfunctionMay 2, 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 6536104 ↗MalfunctionApr 30, 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 6533053 ↗MalfunctionApr 29, 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 6532376 ↗MalfunctionApr 29, 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 6532362 ↗MalfunctionApr 28, 2017Contamination; Contamination
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING CONTAMINATED 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 6528964 ↗MalfunctionApr 27, 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 6525136 ↗MalfunctionApr 26, 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 6521513 ↗MalfunctionApr 26, 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 6521512 ↗InjuryApr 26, 2017Failure to Obtain Sample; Failure to Obtain Sample
ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING A SAMPLE DRAW ISSUE WITH HIS ONETOUCH VERIO TEST STRIPS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED STRIP ISSUE BEGAN ON (B)(6) 2017. THE PATIENT INFORMED THE CSR THAT HE MANAGES HIS DIABETES WITH INSULIN (SELF-ADJUSTER) AND DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ON (B)(6) 2017, 3 WEEKS AFTER THE ALLEGED ISSUE BEGAN, HE DEVELOPED SYMPTOMS OF ¿SHAKY HANDS AND BLURRY VISION.¿ THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS FOLLOWING THE CORRECT TESTING PROCESS. THE CSR NOTED THE TEST STRIP ONLY PARTIALLY FILLED AFTER A SAMPLE WAS APPLIED. THE PRODUCTS INVOLVED IN THE COMPLAINT WERE REQUESTED BACK FOR INVESTIGATION AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT, AFTER THE ALLEGED PRODUCT ISSUE BEGAN.
Patient problems: Blurred Vision; Shaking/Tremors
MAUDE report 6521340 ↗MalfunctionApr 18, 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 6499347 ↗MalfunctionApr 12, 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 6484660 ↗MalfunctionApr 6, 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 6463107 ↗MalfunctionApr 6, 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 6463034 ↗MalfunctionApr 4, 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 6455929 ↗MalfunctionMar 31, 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 6448883 ↗MalfunctionMar 31, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING ERROR UNKNOWN. 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 6448860 ↗MalfunctionMar 31, 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 6448855 ↗MalfunctionMar 30, 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 6445232 ↗MalfunctionMar 28, 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 6438330 ↗MalfunctionMar 28, 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 6438233 ↗
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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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