BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2638698 · Received July 3, 2012

    Report

    Report Number
    2939301-2012-07374
    Event Type
    Malfunction
    Date Received
    July 3, 2012
    Report Date
    June 25, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) IS NOT EXPECTING THE SUBJECT PRODUCTS 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 THE ALLEGED INACCURATE AND ERRATIC RESULTS WERE NOT RESOLVED WITH TROUBLESHOOTING. THE PATIENT CLAIMED THAT THEY OBTAINED BACK TO BACK BLOOD GLUCOSE RESULTS OF "110, 170 250 AND 230 MG/DL" WITH THE SUBJECT METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THESE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3286222

    Patients

    Seq Age Sex Outcome Treatment
    1