BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 854214 · Received March 5, 2007

    Report

    Report Number
    1823260-2007-01846
    Event Type
    Malfunction
    Date Received
    March 5, 2007
    Date of Event
    February 11, 2007
    Report Date
    March 5, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE: COMFORT CURVE TEST STRIPS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 303MG/DL AND 103MG/DL ON THE ADVANTAGE TEST SYSTEM WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. NO QUALITY CONTROLS WERE USED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. NO INDICATION AS TO WHERE COMPARISON WAS PERFORMED. ADVANTAGE TEST SYSTEM: STRIP LOT 549522, EXP 2/29/08, CAT/2030381.

    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 * 549522

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR NOVELIN - 2 YRS 25 UNITS-3XDAY