BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTISTIX 9 SG

    MDR report key: 96615 · Received June 5, 1997

    Report

    Report Number
    MW4001913
    Event Type
    Malfunction
    Date Received
    June 5, 1997
    Date of Event
    May 24, 1997
    Report Date
    May 29, 1997
    Manufacturer
    BAYER CORP. DIAGNOSTICS DIV.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WHEN DIPPED IN DISTILLED WATER, (DEIONIZED), BY RPTR'S CLINICAL CHEMISTRY LAB AS PART OF QC SYSTEM, THIS LOT GAVE FALSE "TRACE POSITIVE" PROTEIN READING ON THE TEST STRIP. SEVEN DIFFERENT INDIVIDUALS CONFIRMED. STRIP IS ALSO HAD "MOTTLED" COLORS AFTER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTISTIX 9 SG BLOOD GLUCOSE TEST STRIP CFR BAYER CORP. DIAGNOSTICS DIV. * D666076

    Patients

    Seq Age Sex Outcome Treatment
    1 *