BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOFILM REAGENT STRIPS

    MDR report key: 230954 · Received June 28, 1999

    Report

    Report Number
    1810909-1999-00005
    Event Type
    Malfunction
    Date Received
    June 28, 1999
    Date of Event
    May 25, 1999
    Report Date
    June 28, 1999
    Manufacturer
    BAYER CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS A TYPE II DIABETIC. HE STATES THAT HE HAS NOTICED A LOWERING OF HIS BLOOD GLUCOSE RESULTS IN THE AM. NORMALLY HIS AM BLOOD SUGAR RUNS IN THE 150-180MG/DL RANGE. HOWEVER, WITH THIS PARTICULAR BOTTLE REAGENT HE NOTICED HIS GLUCOSE VALUES HAVE SHIFTED TO THE 80-100MG/DL RANGE. ON 5/25/99 HE WAS SCHEDULED FOR ROUTINE BLOOD WORK AT A LOCAL HOSPITAL. HE TESTED HIS BLOOD SUGAR AT HOME AND RECEIVED A VALUE OF 85MG/DL. HOWEVER, TWO HOURS LATER (AT THE HOSPITAL) WHILE STILL IN THE FASTING MODE HIS BLOOD SUGAR WAS 192MG/DL (METHOD UNKNOWN). THE CUSTOMER THEN PURCHASED A NEW BOTTLE OF REAGENT AND DECIDED TO DO A SIDE-BY-SIDE COMPARISON. HIS OLDER REAGENT GAVE A RESULT OF 80MG/DL WHILE THE NEWER REAGENT GAVE A 183 MG/DL. (DIFFERENT FINGER STICKS). WHILE ON THE PHONE THE OPERATION OF THE SYSTEM WAS REVIEWED. THE CUSTOMER INDICATES THAT HE STORES HIS REAGENT IN A DRAWER AND HAS NOT CHANGED THE WAY HE HAS HANDLED THE REAGENT FOR THE LAST 4 YEARS. HE ALSO INDICATED THAT HE HAS NEVER RUN A CONTROL TEST. A REQUEST TO RETURN THE SYSTEM FOR EVALUATION WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOFILM REAGENT STRIPS BLOOD GLUCOSE REAGENT CFR BAYER CORP. 2370 8A28A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN