BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2832609 · Received November 14, 2012

    Report

    Report Number
    2939301-2012-13185
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    November 5, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS EXPECTED TO BE RETURNED.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE REPORTER CONTACTED LIFESCAN ALLEGING THE PUMP COMMUNICATION IS SWITCH TO OFF AND EVERY DAY HE HAS TO SET THE PUMP COMMUNICATION BACK TO ON. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3248134

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR