BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3003240 · Received March 14, 2013

    Report

    Report Number
    3008382007-2013-04958
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    February 15, 2013
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFESCAN PRODUCT HAS BEEN RETURNED TO LIFESCAN. EVALUATION HAS NOT YET BEEN COMPLETED. AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/07/2013)-DEVICE EVALUATION: THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) RESPECTIVELY ON (B)(4) 2013 AND (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED TESTING AND NO FAULTS WERE FOUND. THE METER WAS EVALUATED, NO FAULTS WERE FOUND, AND THE METER FUNCTIONED PROPERLY. PA UNABLE TO REPRODUCE THE COMPLAINT. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE CONTROL SOLUTION RESULTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE CONTROL SOLUTION RESULT WAS OUTSIDE THE ACCEPTABLE RANGE. 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
    106815 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3383972

    Patients

    Seq Age Sex Outcome Treatment
    1