BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2200849 · Received August 11, 2011

    Report

    Report Number
    2939301-2011-07231
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    August 3, 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

    FOLLOW-UP # 1 ((B)(6) 2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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. A 510 (K) # IS K073231.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ALLEGING AN ERROR 1 MESSAGE ON HER ONE TOUCH ULTRALINK METER. THE PATIENT MENTIONED THAT THE SHE FIRST NOTICED THE ALLEGED ERROR 1 MESSAGE ON THE MORNING OF (B)(6) 2011. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. DUE TO THE ALLEGED ERROR 1 MESSAGE, THE PATIENT SELF-TREATED WITH INSULIN AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. THE ALLEGED ERROR 1 WAS NOT RESOLVED OVER THE PHONE. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT SINCE THE PATIENT DENIED EXHIBITING ANY SYMPTOMS AND SEEKING ANY MEDICAL ATTENTION. THE COMPLAINT IS BEING REPORTED SINCE THE ALLEGED ERROR 1 MESSAGE WAS NOT RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR