BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1041202 · Received May 9, 2008

    Report

    Report Number
    1823260-2008-03891
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 ACTIVE SYSTEM WITH RESULT OF 11 MG/DL AND 150 MG/DL. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS CORP. 22974232

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR NOVOLOG 7-8 UNITS| LANTUS 24 UNITS PM| CHLORTHALIDONE 1 PILL PM