BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1243250 · Received November 7, 2008

    Report

    Report Number
    1823260-2008-08229
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 14, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THREE COMPACT PLUS STRIP DRUM VIAL LABELS HAVE NO EXPIRATION DATE, LOT NUMBER, OR CATALOGUE NUMBER. NO ALLEGATION OF TORN OR SMEARED LABEL. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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 58 YR LANTUS SLIDING SCALE- 3 YEARS