BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2242387 · Received September 10, 2011

    Report

    Report Number
    2939301-2011-08799
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Report Date
    September 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. 510(K)# IS K073231.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE TEST STRIPS AND CONTROL SOLUTION INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(6) 2011 THE CONTROL SOLUTION WAS TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. HOWEVER, A SECONDARY ISSUE WAS NOTED WHERE THE CONTROL SOLUTION WAS FOUND TO HAVE LOW GLUCOSE CONTENT. ON (B)(6) 2011 THE TEST STRIPS WERE TESTED AND NO FAULTS WERE FOUND. 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

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE INACCURATE CONTROL HIGH WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3157465

    Patients

    Seq Age Sex Outcome Treatment
    1