BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER 3 WITH MEMORY

    MDR report key: 93947 · Received May 21, 1997

    Report

    Report Number
    1810909-1997-00007
    Event Type
    Malfunction
    Date Received
    May 21, 1997
    Date of Event
    April 22, 1997
    Report Date
    May 5, 1997
    Manufacturer
    BAYER CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS THE WIFE OF A DIABETIC. SHE STATES THAT HER HUSBAND'S BLOOD SUGAR ON 4/22/97 (AM) WAS 29-34 MG/DL. SHE THEN TOOK HIM TO THE EMERGENCY ROOM WHERE A BLOOD SUGAR WAS 338 MG/DL (METHOD UNK). IN REVIEW OF THE OPERATION OF THE SYSTEM IT WAS DETERMINED THAT THE CUSTOMER WAS USING REAGENT STRIPS THAT HAVE EXPIRED (9/96).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER 3 WITH MEMORY BLOOD GLUCOSE METER CFR BAYER CORP. 5485M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN