BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM METER

    MDR report key: 1781058 · Received July 25, 2007

    Report

    Report Number
    1823260-2007-06491
    Event Type
    Malfunction
    Date Received
    July 25, 2007
    Date of Event
    July 6, 2007
    Report Date
    July 25, 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
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE THIRD CONTACT FROM THE LEFT ON THE INFORM SYSTEM IS BLACKENED AND THE METER WILL NOT CHARGE. NO ADVERSE EVENTS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA