BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2990056 · Received March 5, 2013

    Report

    Report Number
    3008382007-2013-04260
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 12, 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
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE WERE TESTED AND FAILED FOR CONTROL SOLUTION HIGH; AND THE TEST STRIP VIAL WAS DAMAGED/EXPOSURE. THE PATIENT'S METER HAS WAS ALSO RETURNED AND EVALUATED, AND PASSED ALL TESTING AND THE COMPLAINT WAS NOT CONFIRMED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE WERE TESTED AND FAILED FOR CONTROL SOLUTION HIGH; AND THE TEST STRIP VIAL WAS DAMAGED/EXPOSURE. THE PATIENT'S METER HAS WAS ALSO RETURNED AND EVALUATED, AND PASSED ALL TESTING AND THE COMPLAINT WAS NOT CONFIRMED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94329 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3234473

    Patients

    Seq Age Sex Outcome Treatment
    1