BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 857430 · Received March 6, 2007

    Report

    Report Number
    1823260-2007-01945
    Event Type
    Malfunction
    Date Received
    March 6, 2007
    Date of Event
    February 17, 2007
    Report Date
    March 6, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    k010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 600 MG/DL, 260 MG/DL, AND 258 MG/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. NO INDICATION GIVEN AS TO WHERE COMPARISON PERFORMED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. NO INFO PROVIDED FOR WHERE COMPARISON WAS PERFORMED. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 549522, EXP 02/29/2008, 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 71 YR HYDROLOZINE-1 YR 25MG/2X DAY| METFORMIN-1 YR 850MG 2X DAY| LISINOPRIL-1 YR 40MG/1X DAY| FLUOXETINE-1 YR 20MG/1X DAY| LOVASTATIN-1 YR 40MG/1X DAY| NAMANDA-1 YR 10MG/2X DAY| PLAVIX-6 MONTHS 75MG/1X DAY| PROTONIX-1 YR 40MG/1X DAY| NIFEDIPINE-1 YR 30MG/1X DAY| ASPIRIN-1 YR 81MG/1X DAY| GLIPIZIDE-1 YR 5MG 2 X DAY