BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT PLUS METER

    MDR report key: 1040957 · Received May 2, 2008

    Report

    Report Number
    1823260-2008-03725
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    December 13, 2007
    Report Date
    May 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THE COMPACT PLUS DEVICE PRODUCED A RESULT OF 0MG/DL. NO TREATMENT INFORMATION PROVIDED. REQUESTED RETURN OF SUSPECT DEVICE FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK