BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1011711 · Received March 10, 2008

    Report

    Report Number
    1823260-2008-02251
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES CUSTOMER REPORTEDLY RECEIVED RESULT OF 224 MG/DL ON THE ADVANTAGE SYSTEM AND 70 MG/DL ON PROFESSIONAL DEVICE WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE 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 549517

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR LISINOPRIL - 40 MG 1/DAY| PRAVACHOL - 20 MG 1/DAY| BABY ASPIRIN - 81 MG 1/DAY| HCTZ - 12.5 MG 1/DAY| COREG - 12.5 MG 2/DAY| METFORMIN - 500 MG 2/DAY| NORVASC - 5 MG 1/DAY