BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1181953 · Received September 22, 2008

    Report

    Report Number
    1823260-2008-07079
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 6, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE COMPACT PLUS SYSTEM WITH RESULTS OF 243 MG/DL AND 83 MG/DL, NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. 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 37 YR LANTUS - 1 YEAR| NOVOLIN - 1 YEAR