BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3865076 · Received June 11, 2014

    Report

    Report Number
    2939301-2014-14079
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Report Date
    June 3, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (08/14/2014)-DEVICE EVALUATION: THE PATIENTS¿ TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2014 AND (B)(4) 2014 RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO GIVE AN ERROR 2 WHEN TESTED WITH CONTROL SOLUTION WITH NO ASSIGNABLE CAUSE FOUND. IN ADDITION, A SECONDARY ISSUE WAS NOTED WHEN THE TEST STRIPS WERE FOUND TO HAVE RESULTS BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. 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) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING ERROR 2 STRIP ISSUE. 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
    345939 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3585240

    Patients

    Seq Age Sex Outcome Treatment
    1