Description of Event or Problem · 0
ON (B)(6) 2021, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING A STRIP CUT ISSUE; ABNORMAL SHAPE OF THE TEST STRIP. 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 ON JANUARY 4, 2022. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SUBJECT TEST STRIP LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. IN ADDITION, THE RETAIN TEST STRIPS OF LOT 4790776 WERE SUBJECTED TO VISUAL TESTING. THE RETAIN TEST STRIPS PASSED VISUAL TESTING 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 MARCH 02, 2022, INVESTIGATION WAS COMPLETED. THE REPORTED ISSUE WAS CONFIRMED BASED ON THE PHOTOGRAPHIC EVIDENCE, DUE TO THE PRODUCT NOT BEING RETURNED. THE TEST STRIPS WERE FOUND TO HAVE BEEN MIS-CUT DURING SLITTING AND VIALING. IT HAS BEEN CONFIRMED THAT THE COMPLAINTS FOR THIS HAZARDOUS SITUATION ARE CONTAINED WITHIN THE OVERALL RESIDUAL RISK THRESHOLD THAT IS USED TO MONITOR SAFETY OF THE DEVICE IN THE FIELD. LIFESCAN CONTINUES TO MONITOR THE COMPLAINT RATE AGAINST RISK THRESHOLDS AND TARGETS SET FOR THE DEVICE. CURRENTLY THERE IS NO INDICATION THAT THIS ISSUE REQUIRES FURTHER INVESTIGATION. SHOULD THIS CHANGE, LIFESCAN WILL ESCALATE THE ISSUE PER INTERNAL PROCEDURES. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.