BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2770988 · Received October 3, 2012

    Report

    Report Number
    2939301-2012-11391
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 20, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (SUBMISSION 12/04/2012)-DEVICE EVALUATION: LIFESCAN RECEIVED THE METER AND TEST STRIPS WITH THE COMPLAINT ON (B)(4) 2012. LIFESCAN COMPLETED INVESTIGATIONS WITH THE RETURNED TEST STRIPS ON (B)(4) 2012 AND NOTED THAT THE RETURNED TEST STRIPS PASSED TESTING WITH NO FAULTS FOUND. INVESTIGATION IS ANTICIPATED FOR THE RETURNED METER BUT INVESTIGATION IS NOT COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. THE PRODUCT(S) HAVE NOT YET BEEN EVALUATED; LFS WILL EVALUATE IT/THEM AND INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    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 DOES NOT TURN ON 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. 3330263

    Patients

    Seq Age Sex Outcome Treatment
    1