BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2884268 · Received December 22, 2012

    Report

    Report Number
    3008382007-2012-08836
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Report Date
    December 4, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (02/15/2013)-DEVICE EVALUATION: THE METER AND CONTROL SOLUTION INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 AND (B)(4) 2013 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE COMPLAINT WAS ALSO NOT CONFIRMED WITH CONTROL SOLUTION BUT A SECONDARY ISSUE UNRELATED TO THE COMPLAINT WAS FOUND. THE CONTROL SOLUTION WAS FOUND TO HAVE GLUCOSE CONTENT ABOVE SPECIFICATIONS. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SECOND FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE LOW RESULTS WITH THE CONTROL SOLUTION WHEN COMPARED TO THE TEST STRIP VIAL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED 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
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3360185

    Patients

    Seq Age Sex Outcome Treatment
    1