BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1912074 · Received December 1, 2010

    Report

    Report Number
    2939301-2010-10408
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Report Date
    November 29, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    FOLLOW-UP #1 (SUBMISSION 09/24/2012)-DEVICE EVALUATION: LIFESCAN RECEIVED THE TEST STRIPS INVOLVED WITH THE COMPLAINT AND COMPLETED DEVICE EVALUATION ON (B)(4) 2010. THE RETURNED TEST STRIPS PASSED TESTING. INVESTIGATION DID NOT CONFIRM THE ALLEGED COMPLAINT.

    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 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. 3009504

    Patients

    Seq Age Sex Outcome Treatment
    1