BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST CHOICE GLUCOSE TEST STRIP

    MDR report key: 16820 · Received October 14, 1994

    Report

    Report Number
    MW1003687
    Event Type
    Malfunction
    Date Received
    October 14, 1994
    Report Date
    October 13, 1994
    Manufacturer
    POLYMER TECHNOLOGY INTERNATIONAL CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE STRIPS ARE GIVING INACCURATE RESULTS. THE RPTR IS AWARE OF ONE PT WHO, ON THREE OCCASIONS, HAD RESULTS VERIFIED BY A LABORATORY. THE RPTR STATED THAT, IN DISCUSSIONS WITH OTHER PHARMACISTS AND TECHNICIANS, HE HAS LEARNED THAT OTHER PTS HAVE ALSO COMPLAINED OF INACCURATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST CHOICE GLUCOSE TEST STRIP CFR POLYMER TECHNOLOGY INTERNATIONAL CORP. F21572

    Patients

    Seq Age Sex Outcome Treatment
    1 *