BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1002488 · Received February 25, 2008

    Report

    Report Number
    1823260-2008-01830
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    December 3, 2007
    Report Date
    February 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BEING SYMPTOMATIC OF HYPOGLYCEMIA WITH BLOOD GLUCOSE RESULT OF 112 MG/DL OBTAINED ON THE ADVANTAGE SYSTEM. THE CUSTOMER WAS TAKEN TO THE HOSPITAL WITHIN 8 MINUTES, AND OBTAINED RESULT OF 41 MG/DL ON A PROFESSIONAL METER. THE CUSTOMER WAS HOSPITALIZED FOR UNRELATED HEALTH CONCERNS, BUT REPORTS BEING TREATED FOR LOW BLOOD GLUCOSE. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 550013

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention GLUCOPHAGE DOSE UNK