BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2821290 · Received November 6, 2012

    Report

    Report Number
    2939301-2012-12799
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 25, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 HIGH COMPARED TO ANOTHER METER. THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "450 MG/DL" WITH ANOTHER METER AND AN UNSPECIFIED RESULT FROM A LIFESCAN METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. ALTHOUGH THE OTHER RESULT WAS NOT SPECIFIED, THE CUSTOMER SERVICE REPRESENTATIVE NOTED THAT THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS BASED ON THE REPORTERS STATEMENT EXCEEDED THE EXPECTED VALUE OF <= 30% AND/OR <= 30 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.

    Patients

    Seq Age Sex Outcome Treatment
    1