BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1884300 · Received October 27, 2010

    Report

    Report Number
    2939301-2010-09535
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109. THIS DEVICE HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE (METER) INVOLVED IN THIS CASE HAS FAILED FUNCTIONAL TESTING DUE TO PCB CONTAMINATION. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. 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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2010 ALLEGING THAT THEIR METER WAS REVERTING TO THE SET UP MODE. THE PATIENT MENTIONED THAT THE REPORTED ISSUE WITH THE METER BEGAN ON (B)(6) 2010 AT 3:00PM. THE PATIENT DID NOT TAKE ANY ACTION AFTER THE ALLEGED ISSUE BEGAN. AT 8:00PM, THE PATIENT DEVELOPED FREQUENT URINATION AND DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT AND THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE PATIENT MENTIONED THAT THEY HAVE NOT REPLACED THE BATTERY. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED ISSUE, THE PATIENT LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2998236

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening