BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® NANO

    MDR report key: 3213118 · Received July 9, 2013

    Report

    Report Number
    1823260-2013-04137
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 1, 2013
    Report Date
    August 21, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K113137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    UPON INVESTIGATION, MANUFACTURER'S FIRST LEVEL INVESTIGATION UNIT CONFIRMED THE NANO METER FOR ELECTRICAL SHORT. NO ADVERSE EVENT REPORTED. THE DEVICE WAS RETURNED, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312372 ACCU-CHEK ® NANO BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1