BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 861851 · Received March 28, 2007

    Report

    Report Number
    1823260-2007-02469
    Event Type
    Malfunction
    Date Received
    March 28, 2007
    Date of Event
    December 1, 2006
    Report Date
    March 28, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 206 MG/DL AND 85 MG/DL ON THE ADVANTAGE TEST SYSTEM WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER, STRIPS ARE UNAVAILABLE FOR RETURN. NO INFORMATION REPORTED TO INDICATE WHERE COMPARISON WAS PERFORMED. ADVANTAGE TEST SYSTEM: METER, TEST STRIP LOT 549512, EXP 02/29/2008, 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 * 549512

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR LASIX - 1 YR 40MG/ 1X DAY| LANTUS - 1 YR 20 UNITS/ 1X DAY| EVISTA - 2 YRS 60MG/ 1X DAY| CADUET 2 YRS 10-10MG/1X DAY| NOVOLOG - 1 YR 4 UNITS/ 1X DAY| ALLOPURINOL - 1 MONTH 50MG/ 1X DAY| NOVOLIN - 1 YR 10 UNITS/ 1X DAY| TOPROL XL 2 YRS 50MG/1X DAY| NEXIUM 2 YRS 40MG/1X DAY