BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIP

    MDR report key: 14540001 · Received May 30, 2022

    Report

    Report Number
    3008382007-2022-04311
    Event Type
    Malfunction
    Date Received
    May 30, 2022
    Report Date
    June 28, 2022
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    CGA
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LAY USER/PATIENT¿S TEST STRIPS HAVE BEEN FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE STRIP RESPONSE FROM ADDITIONAL PERFORMANCE TESTING ON THE CUSTOMER RETURNED STRIPS INCLUDED ERROR 4 AND INACCURATE CONTROL LOW WHICH ARE BOTH ATTRIBUTABLE TO THE PRIMARY DIAGNOSTIC DEFECT OF THE TEST STRIP BEING MIS CUT. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE REPORTER CONTACTED LIFESCAN ALLEGING BENT 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 (B)(6) 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 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. THE LAY USER/PATIENT¿S STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED FUNCTIONAL TESTING WITH NO FAULTS FOUND. ON (B)(6) 2022, INVESTIGATION WAS COMPLETED. THE REPORTED ISSUE WAS CONFIRMED. THE TEST STRIPS WERE FOUND TO HAVE BEEN MIS-CUT DURING SLITTING AND VIALING. THIS INVESTIGATION HAS NOT IDENTIFIED ANY EVIDENCE THAT THERE IS A SYSTEMIC ISSUE WITHIN LOT 4812083 RELATING TO MISCUT STRIPS. NO FURTHER ESCALATION IS REQUIRED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2713360 OT VERIO TEST STRIP GLUCOSE MONITORING SYS/KIT CGA LIFESCAN EUROPE GMBH 4812083

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown