BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 864957 · Received March 5, 2007

    Report

    Report Number
    1823260-2007-01844
    Event Type
    Malfunction
    Date Received
    March 5, 2007
    Date of Event
    February 4, 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
    NE, 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 320MG/DL AND 142MG/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. INFO SUGGESTS COMPARISON PERFORMED IN THE HOME. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 549250, EXP 11/30/2007, CAT/2030373.

    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 * 549250

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR SYNTHROID - SEVERAL YRS 50MG, 1 X A DAY| METOPROLOL - SEVERAL YRS 50MG, 2 X A DAY| PAROXETINE - SEVERAL YRS 10MG, 1 X A DAY| ATTENOLOL - SEVERAL YRS 35MG, 1 X A WEEK| ENALAPRIL - SEVERAL YRS 20MG, 2 X A DAY| VYTORIN - SEVERAL YRS 10/40 M/S 1 X A DAY| LANTUS - 6 MONTHS, 18 UNITS 1 X A DAY