BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM

    MDR report key: 1781029 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06532
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    July 16, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    Z-1060-04
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON EVALUATION BY MANUFACTURER CONTACTS 3 AND 4 ON THE INFORM METER WERE FOUND TO BE MELTED AND BURNED. NO ADVERSE EVENT REPORTED. ACCU-CHEK CUSTOMER CARE SERVICE CENTER REPLACED METER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention