BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOFILM

    MDR report key: 75188 · Received March 11, 1997

    Report

    Report Number
    MW4001802
    Event Type
    Malfunction
    Date Received
    March 11, 1997
    Date of Event
    February 7, 1997
    Report Date
    February 20, 1997
    Manufacturer
    BAYER CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THREE REPORTS OF ABNORMAL BG READINGS (10-15 PTS HIGHER THAN NORMAL) FROM 3 SEPARATE LOCATIONS IN THE HOSP. GLUCOMETERS WERE TESTED AND HISTORY REPORTS RUN ALL OK. PULLED LOT THROUGHOUT THE HOSP. CLINICAL LABORATORIES AT HOSP VERIFIED ACCURACY OF GLUCOMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOFILM BLOOD GLUCOSE TEST STRIPS CFR BAYER CORP. * C773036

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other