BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1770533 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09213
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 4, 2007
    Report Date
    October 22, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE COMPACT PLUS SYSTEM WITH RESULTS OF: HI (>600MG/DL) AND 120MG/DL, HI (>600MG/DL) AND 50MG/DL, 120MG/DL AND 50MG/DL. L1 QUALITY CONTROLS WERE RUN AND IN RANGE. 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 COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 20669741

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR HUMALOG - SLIDING SCALE| LANTUS - 25U BEFORE BED