BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2930892 · Received January 28, 2013

    Report

    Report Number
    3008382007-2013-01589
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 4, 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
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE ERRATIC RESULTS. THE REPORTER CLAIMED TO HAVE OBTAINED BLOOD GLUCOSE READINGS OF "442, 217, 485, 365, AND 280 MG/DL" WITH THE SUBJECT METER PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE REPORTER ALSO CLAIMED TO HAVE OBTAINED READING OF "64 AND 241 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCURACY/PRECISION 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
    37534 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3383260

    Patients

    Seq Age Sex Outcome Treatment
    1