BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 1180904 · Received September 24, 2008

    Report

    Report Number
    1823260-2008-07127
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    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

    THE CUSTOMER REPORTS THAT THE "DAY" ICON IS MISSING ON THE ACCU-CHEK COMPACT PLUS METER. THIS WAS DISCOVERED DURING DISPLAY CHECK WITH THE ACCU-CHEK CALL AGENT. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR HUMALOG| LANTUS