BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3121404 · Received May 20, 2013

    Report

    Report Number
    3008382007-2013-12335
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 26, 2013
    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
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATELY HIGH RESULTS WITH THE SUBJECT METER COMPARED TO AN ICU METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE REPORTER INDICATED THAT THE METER READING ON THE SUBJECT DEVICE WAS "52 POINTS TO 49 POINTS" HIGHER THAN THE ICU METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S ACCURACY CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH 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
    221602 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3377117

    Patients

    Seq Age Sex Outcome Treatment
    1