BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 864988 · Received March 5, 2007

    Report

    Report Number
    1823260-2007-01843
    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
    OH, 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 343MG/DL AND 138 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE TEST SYSTEM. CUSTOMER STATES THEY TOOK NORMAL INSULIN AFTER THE RESULT OF 138 MG/DL. NO ADVERSE EVENT REPORTED. NO QUALITY CONTROLS WERE USED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. NO INDICATION GIVEN FOR WHERE COMPARISON PERFORMED. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 549202, EXP 9/30/07, CAT/2030365.

    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 * 549202

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HUMULIN R - 2 UNITS AM AND PM| ACTOS - 1/2 TAB AM AND PM| HUMULIN N - 10 UNITS AM AND PM