BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 6310121 · Received February 8, 2017

    Report

    Report Number
    3008382007-2017-06685
    Event Type
    Malfunction
    Date Received
    February 8, 2017
    Report Date
    February 3, 2017
    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
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING OBTAINING INACCURATELY LOW CONTROL SOLUTION RESULTS. THE REPORTER CLAIMED OBTAINING CONTROL SOLUTION RESULTS OF ¿121, 122 AND 120 MG/DL¿ WHICH FELL BELOW THE SPECIFIED CONTROL SOLUTION RANGE PRINTED ON THE TEST STRIP VIAL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY CONTROL 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
    94961 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3983932

    Patients

    Seq Age Sex Outcome Treatment
    1