BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 352422 · Received September 17, 2001

    Report

    Report Number
    1823260-2001-00213
    Event Type
    Injury
    Date Received
    September 17, 2001
    Date of Event
    September 7, 2001
    Report Date
    September 7, 2001
    Manufacturer
    ROCHE DIAGNOSITCS
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S FAMILY MEMBER CALLED TO REPORT THAT THE SUSPECT DEVICE WAS USED TO CHECK PT'S BLOOD GLUCOSE. A RESULT OF 185MG/DL WAS OBTAINED AROUND 6:48AM AND PT TOOK THEIR NORMAL MEDS. AROUND 9:52AM PT WAS SYMPTOMATIC OF HYPOGLYCEMIA AND THE SUSPECT DEVICE WAS USED AND THE RESULT WAS 182MG/DL, THEN A RESULT OF 139MG/DL AT 10:00AM. EMT'S WERE THEN CALLED. PT'S BLOOD GLUCOSE WAS 28MG/DL ON THE EMT'S METER. PT WAS THEN TREATED FOR HYPOGLYCEMIA WITH UNKNOWN TREATMENT. AFTER TREATMENT THE EMT'S METER READ 130MG/DL AND THE SUSPECT DEVICE READ 363MG/DL. GLUCOSE CONTROL SOLUTIONS WERE NOT USED ON THE SUSPECT DEVICE SYSTEM. THE SUSPECT DEVICE WAS REPLACED WITH NEW PRODUCT AND AUTHORIZED FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42321 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING TEST STRIPS CFR ROCHE DIAGNOSITCS NA 545490

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention