BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 4150711 · Received October 8, 2014

    Report

    Report Number
    2939301-2014-26798
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 23, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVICE EVALUATION. ON (B)(6) 2014 THE PATIENT¿S METER WAS EVALUATED WITH FAILING RESULTS. PRODUCT ANALYSIS FOUND THE METER TO HAVE A DEFECTIVE CRYSTAL X1. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632590 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3599195

    Patients

    Seq Age Sex Outcome Treatment
    1