ONETOUCH VERIO

Additional Manufacturer Narrative

SEE INCIDENT DESCRIPTION (SECTION B5) FOR DEVICE EVALUATION.

Description of Event or Problem

ON JUNE 18, 2025, THE REPORTER CONTACTED LIFESCAN ALLEGING A STRIP CUT ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. SIMILAR COMPLAINTS FOR THIS ISSUE WERE TRENDED FOR THE TEST STRIP LOT. IT WAS CONCLUDED THAT THE NUMBER OF COMPLAINTS FOR THE LOT DID NOT BREACH THRESHOLDS INDICATIVE OF A SYSTEMIC ISSUE. THE COMPLAINT WAS FURTHER INVESTIGATED BASED ON PHOTOGRAPHIC EVIDENCE RECEIVED. A BATCH RECORD REVIEW WAS COMPLETED FOR THE SUBJECT TEST STRIP LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. IN ADDITION, VISUAL INSPECTION OF RETAINED TEST STRIPS WAS PERFORMED. THE RETAINED TEST STRIPS PASSED VISUAL INSPECTION WITH NO DEFECTS IDENTIFIED. LIFESCAN ALSO CONDUCTED A STRIP LOT EVALUATION AND CONCLUDED THAT THE COMPLAINTS ASSOCIATED TO THIS LOT DO NOT REQUIRE ESCALATION AND NO SYSTEMIC ISSUE WAS OBSERVED. ON JULY 17, 2025, THE TEST STRIPS WERE RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS FAILED VISUAL INSPECTION. THE REPORTED ISSUE WAS CONFIRMED. THE TEST STRIPS WERE FOUND TO HAVE BEEN MISCUT DURING SLITTING AND VIALING. THIS INVESTIGATION HAS NOT IDENTIFIED ANY EVIDENCE THAT THERE IS A SYSTEMIC ISSUE WITHIN LOT 5881880 RELATING TO MISCUT STRIPS. NO FURTHER ESCALATION IS REQUIRED AT THIS TIME. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.