BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1181015 · Received September 29, 2008

    Report

    Report Number
    1823260-2008-07224
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 21, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    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 REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF: 525MG/DL AND 105MG/DL. FIVE HUNDRED TWENTY MG/DL AND 201MG/DL. QUALITY CONTROLS WERE EXPIRED. 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS CORP. 550690

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR COUMADIN| NALSPAN| ACCUPRIL| NOVOLOG| LANTUS| LASIX| "ENFORCE" - 6 MONTHS| TRICOR| COREG