BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2822721 · Received November 7, 2012

    Report

    Report Number
    2939301-2012-12866
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 26, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 A PATIENT CONTACTED LIFESCAN ALLEGING THAT THE SUBJECT METER READ INACCURATELY ERRATIC COMPARED TO THE SAME METER. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "202 MG/DL" AND "117 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. 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. 3319253

    Patients

    Seq Age Sex Outcome Treatment
    1