BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2890047 · Received December 28, 2012

    Report

    Report Number
    3008382007-2012-09133
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Report Date
    December 7, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER WAS PROMPTING AN ERROR 2 MESSAGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED METER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING. THERE IS NO INDICATION THAT THE ALLEGED ISSUE CAUSED AND/OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1