BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOFILM

    MDR report key: 370634 · Received January 4, 2002

    Report

    Report Number
    MW1023774
    Event Type
    Malfunction
    Date Received
    January 4, 2002
    Date of Event
    December 28, 2001
    Report Date
    January 4, 2002
    Manufacturer
    BAYER CORP, DIAGNOSTICS DIV
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2001, THE RPTR PURCHASED DIABETIC TEST STRIPS FROM THE DRUG STORE. AFTER ATTEMPTING TO USE THE STRIPS, THE RPTR DISCOVERED THAT THE EXPIRATION DATE ON THE STRIPS WAS 06/2001. THE GLUCOMETER ELITE TEST STRIPS ARE ENTIRELY DIFFERENT FROM THE GLUCOFILM TEST STRIPS PLUS THE GLUCOFILM TEST STRIPS ARE OUT OF DATE BY 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOFILM GLUCOSE TEST STRIPS CFR BAYER CORP, DIAGNOSTICS DIV * 9M03A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other