BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3914926 · Received July 5, 2014

    Report

    Report Number
    2939301-2014-16487
    Event Type
    Malfunction
    Date Received
    July 5, 2014
    Report Date
    June 27, 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
    NC, 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 READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿369MG/DL¿ WITH THE SUBJECT METER AND ¿229MG/DL¿ ON A ¿TRUE TEST¿ METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, 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
    392949 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3547252

    Patients

    Seq Age Sex Outcome Treatment
    1