BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM BASE

    MDR report key: 3163091 · Received June 11, 2013

    Report

    Report Number
    1823260-2013-03536
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    UPON REVIEW BY THE MANUFACTURER'S INVESTIGATION UNIT, THE INFORM BASE UNIT SHOWED SIGNS OF AN ELECTRICAL SHORT. THE CONNECTOR PINS ARE CHARRED, AND THE PLASTIC HOUSING IN THE AREA IS MELTED. NO ADVERSE EVENT REPORTED. SUSPECT DEVICE WAS RETURNED AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263784 ACCU-CHEK ® INFORM BASE BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1