BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1891441 · Received November 4, 2010

    Report

    Report Number
    2939301-2010-09685
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109. 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.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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.

    Description of Event or Problem · 1

    THE LAY REPORTER CONTACTED LFS ON (B)(6), 2010 ALLEGING THAT THE PATIENT'S ONE TOUCH ULTRA METER POWERS OFF DURING USE. THE REPORTER MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6), 2010 AT 7:30AM. DUE TO THE ALLEGED ISSUE, THE PATIENT CONTINUED TO TAKE THEIR USUAL DOSAGE OF MEDICATION. ON (B)(6), 2010 AT AROUND 12:30PM, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY. THE PATIENT DID NOT SELF-TREAT OR SEEK ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT. THE BATTERY NEEDED TO BE REPLACED AND THE PATIENT DID NOT HAVE REPLACEMENT BATTERIES AT THE TIME OF THE INITIAL CALL. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE METER POWERING OFF DURING USE, THE PATIENT WAS UNABLE TO TEST AND A COUPLE OF DAYS LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE DEVICE CENTER, THE SERVICE TECHNICIAN REPORTED THE ARTERIAL BLOOD PARAMETER PROBE FAILED THE MANUFACTURING STANDARD REFERENCE SENSOR TEST. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3043138

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening