BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 4120471 · Received September 26, 2014

    Report

    Report Number
    2939301-2014-25529
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 18, 2014
    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
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA ALLEGING THAT THE SUBJECT METER (ONETOUCH ULTRALINK) READ INACCURATELY HIGH COMPARED TO OTHER DEVICES. THE REPORTER CLAIMED OBTAINING A BLOOD GLUCOSE READING OF "108MG/DL" WITH THE SUBJECT METER AND BETWEEN "65-70MG/DL" ON ANOTHER DEVICE, PERFORMED AN UNKNOWN TIME BETWEEN ONE ANOTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. IN ADDITION, THE REPORTER CLAIMED OBTAINING AN UNKNOWN BLOOD GLUCOSE READING WITH THE SUBJECT METER AND ANOTHER UNKNOWN READING ON ANOTHER DIFFERENT DEVICE, PERFORMED AN UNKNOWN TIME BETWEEN ONE ANOTHER. IT IS NOT KNOWN IF THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED 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
    600889 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3649934

    Patients

    Seq Age Sex Outcome Treatment
    1