BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 39383 · Received September 20, 1996

    Report

    Report Number
    1823260-1996-00100
    Event Type
    Injury
    Date Received
    September 20, 1996
    Date of Event
    September 11, 1996
    Report Date
    September 12, 1996
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    TYPE I DIABETIC HAD BEEN OBTAINING BLOOD GLUCOSE VALUES FROM THE DEVICE WHICH WERE GREATER THAN 200 MG/DL. ON DAY OF EVENT, DIABETIC BEGAN "ACTING STRANGE". SO FAMILY CONTACTED MEDICS. MEDICS DETERMINED BLOOD GLUCOSE TO BE 40 MG/DL BY AN UNKNOWN METHOD. DIABETIC WAS TREATED WITH INTRAVENOUS GLUCOSE. QUALITY CONTROL SOLUTIONS WERE OUTSIDE OF RANGE INDICATING THAT THE TEST STRIPS WERE DAMAGED BY IMPROPER STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITORING TEST STRIPS CFR BOEHRINGER MANNHEIM CORP. 7689METER) 400299(STRIPS)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention