BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 858511 · Received March 13, 2007

    Report

    Report Number
    1823260-2007-02050
    Event Type
    Malfunction
    Date Received
    March 13, 2007
    Date of Event
    February 15, 2007
    Report Date
    March 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 425MG/DL, 211MG/DL, AND 124MG/DL ON THE ADVANTAGE TEST SYSTEM WITHIN 10 MINUTES. CUSTOMER TOOK HIS NORMAL MEDICATION IN RESPONSE TO THE RESULTS. NO ADVERSE EVENT REPORTED. NO QUALITY CONTROLS WERE USED. NO INFORMATION PROVIDED TO INDICATE WHERE COMPARISON PERFORMED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. ADVANTAGE TEST SYSTEM: STRIP LOT 549424, EXP 11/30/2008, 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 * 549424

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR CARDIZEM 5 YEARS 300MG/1X PER DAY| HUMULIN 3 YEARS SLIDING SCALE/1X| PRANDIN 3 YEARS 2MG/4X PER DAY| ZETIA 6 MONTHS 10MG/1X PER DAY| HUMALOG 5 YEARS 300MG| ZOLOFT 4 YEARS 50MG/1X PER DAY| PLAVIX 1 YEAR 75 MG/1X PER DAY| ACTOS 3 YEARS 45MG/1X PER DAY