BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1900849 · Received November 17, 2010

    Report

    Report Number
    2939301-2010-09978
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    November 3, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (SUBMISSION 09/21/2012)-DEVICE EVALUATION: LIFESCAN RECEIVED THE CONTROL SOLUTION AND TEST STRIPS INVOLVED WITH THE COMPLAINT AND COMPLETED DEVICE EVALUATION ON (B)(4) 2011, RESPECTIVELY. INVESTIGATION DID NOT CONFIRM THE ALLEGED COMPLAINT WITH THE CONTROL SOLUTION; HOWEVER, THE TEST STRIPS FAILED TESTING. THE RETURNED TEST STRIPS READ ABOVE EXPECTED RANGE WITH A CONTROL SOLUTION TEST.

    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. THE 510(K)# IS K073231.

    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. 2965315

    Patients

    Seq Age Sex Outcome Treatment
    1