BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITE METER FREESTYLE

    MDR report key: 10790605 · Received November 5, 2020

    Report

    Report Number
    2954323-2020-09862
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    November 3, 2020
    Report Date
    December 9, 2020
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    UDI-DI
    00699073708052
    PMA / PMN Number
    K092602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED METER WAS INVESTIGATED WITH RETAINED TEST STRIPS. METER DID NOT POWER ON WITH BUTTON DEPRESSION OR TEST STRIP INSERTION. PQE SUPPLIED POWER STRAIGHT THE THE PCBA, BYPASSING THE BATTERY AND BATTERY HOLDER, METER WAS ABLE TO POWER ON. METER WAS OBSERVED TO HAVE BEEN USED FOR 17 STRIP READINGS FROM 15MAR20 TO 31OCT20. PQE PERFORMED A VISUAL INSPECTION AND OBSERVED EVIDENCE OF LIQUID ON PCBA. PQE ALSO OBSERVED OXIDATION ON BATTERY HOLDER PINS PREVENTING THE METER TO ACKNOWLEDGE BATTERY. A KNOWN GOOD BATTERY HOLDER BACK CASING WAS USED IN MIX-MATCH TESTING AND METER WAS ABLE TO POWER ON. OXIDATION ON BATTERY PINS LIKELY DUE TO EXPOSURE TO MOISTURE. ALTHOUGH GLUCOSE RESULTS MAY BE DELAYED, BLOOD GLUCOSE COULD BE DETERMINED BY ALTERNATE MEANS, INCLUDING USE OF ANOTHER BLOOD GLUCOSE METER, SEEING A PHYSICIAN (AS RECOMMENDED IN PRODUCT LABELING), OR BY SEEKING TREATMENT AT A HEALTH CARE FACILITY. ISSUE IS NOT CONFIRMED DUE TO USE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    AN EXTENDED INVESTIGATION HAS BEEN CONDUCTED, WHICH INVOLVED A MANUFACTURING REVIEW (INCLUDING 5 YEARS OF DEVICE HISTORY RECORDS (DHRS)), PREVIOUS COMPLAINT AND CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATIONS CONDUCTED FOR BLANK SCREEN ISSUES, PROCESS FAILURE MODE EFFECTS ANALYSES (PFMEAS), DESIGN CONTROLS, AND DESIGN FAILURE MODE EFFECTS ANALYSES (DFMEAS), RISK MANAGEMENT REPORTS, RISK EVALUATIONS, AND LABEL COPY. THE INVESTIGATION DID NOT IDENTIFY ANY INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. IF THE PRODUCT IS RETURNED, AN INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261312 LITE METER FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 70805-70 00699073708052

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR