BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUCHEK INSTANT

    MDR report key: 184348 · Received August 26, 1998

    Report

    Report Number
    1823260-1998-00101
    Event Type
    Injury
    Date Received
    August 26, 1998
    Date of Event
    August 7, 1998
    Report Date
    August 7, 1998
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A TYPE 2 DIABETIC WAS GETTING LOW RESULTS FOR BLOOD GLUCOSE ON THE SUSPECT DEVICE. AT THE DR'S IT WAS DETERMINED THAT PATIENT'S BLOOD GLUCOSE WAS 300+ MG/DL. THE PATIENT HAD STOPPED TAKING HIS MICRONASE AND GLUCOSIDE AND WAS EATING MORE SUGAR FOODS TO TRY TO ELEVATE HIS GLUCOSE PRIOR TO THE DR'S VISIT. THE LEVEL ONE CONTROL TESTED "OOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUCHEK INSTANT BLOOD GLUCOSE MONITORING DEVICE CFR BOEHRINGER MANNHEIM CORP. 913 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other