BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOSE MONITORING SYS/KIT

    MDR report key: 3811664 · Received May 15, 2014

    Report

    Report Number
    2939301-2014-11371
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    May 1, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA ALLEGING THAT THE SUBJECT METER DISPLAYED AN ERROR 1 MESSAGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING. 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
    291967 GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3588863

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR