BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1141423 · Received September 3, 2008

    Report

    Report Number
    1823260-2008-05494
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 597MG/DL AND 199MG/DL ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    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 550082

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR LASIX - 120MG/DAY| ASPIRIN - 81MG/DAY| NORVASC - 10MG/DAY| LIPITOR - 40MG/DAY| HCTZ - 25MG/DAY| ZETIA - 10MG/DAY| NOVOLIN 70/30 - 52 UNITS/DAY| HYDRALAZINE - 175MG/DAY| DIGOXIN - 0.125MG/DAY| PLAVIX - 75MG/DAY| COREG - 50MG/DAY| CATAORES - WEEKLY| POTASSIUM - 30MG/DAY| ZANTAC - 300MG/DAY