BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1181014 · Received September 29, 2008

    Report

    Report Number
    1823260-2008-07223
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 21, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE COMPACT SYSTEM WITH RESULTS OF 130MG/DL AND 300MG/DL. QUALITY CONTROLS WERE EXPIRED. NO ADVERSE EVENT REPORTED. CALLER REPORTS CUSTOMER NO LONGER HAS STRIPS; A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR LANTUS - 3 YEARS| METFORMIN - 6 YEARS