ONETOUCH VERIO

Additional Manufacturer Narrative

SEE INCIDENT DESCRIPTION (B5) FOR DEVICE EVALUATION.

Description of Event or Problem

ON SEPTEMBER 08, 2025, THE REPORTER CONTACTED LIFESCAN ALLEGING A STRIP ISSUE OF LASER MARKED (ABLATED) STRIPS. 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 LAY USER/PATIENT¿S STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE RETURNED TEST STRIPS WAS PERFORMED. THE REPORTED ISSUE WAS CONFIRMED. IN ADDITION, A BATCH RECORD REVIEW WAS PERFORMED ON THE SUBJECT TEST STRIP LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. VISUAL INSPECTION OF RETAINED PRODUCT WAS PERFORMED. THE RETAIN 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 JANUARY 06, 2026, INVESTIGATION WAS COMPLETED, CONFIRMING THE COMPLAINT OF LASER MARKED (ABLATED) STRIPS. THIS INVESTIGATION HAS NOT IDENTIFIED ANY EVIDENCE THAT THERE IS A SYSTEMIC ISSUE WITHIN LOT 5885566 RELATING TO ABLATED STRIPS. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.