OneTouch Verio 022-269Recalls & 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
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00353885007726), received between Dec 18, 2016 and Apr 25, 2017 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Bent” (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. 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 Available4
- Bent3
- Failure to Obtain Sample3
- Off-Label Use2
- Sticking1
Patient problems
- No Consequences Or Impact To Patient13
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
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 6517871 ↗MalfunctionApr 7, 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 6471063 ↗MalfunctionMar 9, 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 6390506 ↗MalfunctionFeb 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 6363570 ↗MalfunctionFeb 20, 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 6342701 ↗MalfunctionJan 26, 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 6278552 ↗MalfunctionJan 21, 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 6268915 ↗MalfunctionJan 18, 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 6259435 ↗MalfunctionJan 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON 01/06/2017, 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 6252276 ↗MalfunctionJan 11, 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 6239985 ↗MalfunctionJan 8, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2016, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING PACKAGING 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 6232014 ↗MalfunctionDec 22, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2016, 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 6197664 ↗MalfunctionDec 18, 2016Failure to Obtain Sample; Failure to Obtain Sample
ON (B)(6) 2016, 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 6184368 ↗
Other SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER devices
- OneTouch Verio Flex 023-271LifeScan Europe GmbH · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER3,703 reports
- FreeStyle Libre 2 71953Abbott Diabetes Care Inc · System, test, blood glucose, over the counter2 recalls1 death3,286 reports
- OneTouch Ultra2 021-105LifeScan U.S. LLC · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER1,731 reports
- Omnipod DASH PDM PDM-USA1-D001-MG-USA1Insulet Corporation · System, Test, Blood Glucose, Over The Counter1 recall10 deaths1,129 reports
- Omnipod UST400Insulet Corporation · System, Test, Blood Glucose, Over The Counter12 deaths816 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALETrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter418 reports
- FreeStyle Freedom Lite 70923-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Lite 70829-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page