BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1033161 · Received April 23, 2008

    Report

    Report Number
    1823260-2008-03459
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT OF HYPOGLYCEMIA IN WHICH SHE HAD METER RESULT OF "120'S" MG/DL ON HER ADVANTAGE SYSTEM AND 70 MG/DL ON EMT'S METER WITHIN 10 MINUTES. CUSTOMER SELF TREATED, EMT'S WERE CALLED BUT DID NOT TREAT. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550507

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HUMALOG SLIDING SCALE/4/DAY