BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3011975 · Received March 20, 2013

    Report

    Report Number
    3008382007-2013-05632
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 20, 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
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATELY HIGH RESULTS COMPARED TO ANOTHER METER. THE REPORTER ALLEGED 5 MINUTES PRIOR TO THE START OF THE ALLEGED ISSUE, SHE FELT "SHAKY." THE REPORTER STATED SHE OBTAINED READINGS OF "273MG/DL" COMPARED TO "73MG/DL" ON AN OT ULTRAMINI METER. 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. THE REPORTER STATED THE ALLEGED ISSUE OCCURRED PRIOR TO THE START OF THE ALLEGED ISSUE, THEREFORE, THE METER COULD NOT HAVE CAUSED THE ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115300 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3315858

    Patients

    Seq Age Sex Outcome Treatment
    1