BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 1002661 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01381
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE COMPACT PLUS SYSTEM PRODUCED AN UNDOSED RESULT OF 43MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT RELATED TO THE DEVICE REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 48 YR LANTUS 40 UNITS AT BREAKFAST 1 YR| HUMALOG SLIDING SCALE SEVERAL YRS