BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760917 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06198
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED OBTAINING BACK TO BACK BLOOD GLUCOSE RESULTS OF 35 MG/DL AND 150 MG/DL ON THE ADVANTAGE SYSTEM. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A 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 549630

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR AMARYL 2 MG ONCE DAILY| SYNTHROID .088MG ONCE DAILY| PLAVIX 75MG ONCE DAILY| ALTACE 10MG ONCE DAILY - 2 WKS| ACTOS 45MG ONCE DAILY| VYTORIN 10-40MG ONCE DAILY