BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1070124 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05216
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 RESULTS OF LO (<10MG/DL) AND 97MG/DL. 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 ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 22981031

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR VICODIN - 15 DAYS| PLAVIX - 7 MOS| DYAZIDE - 20YRS| TAGAMET - SINCE 20YRS OLD| FENTANYL PATCHES - 3 MOS| LORATADINE - 10YRS| HUMALOG 75/25 - 1.5 MONTH| COMPAZINE - 15-20YRS