BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1896781 · Received November 10, 2010

    Report

    Report Number
    2939301-2010-09789
    Event Type
    Injury
    Date Received
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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. HOWEVER A SECONDARY ISSUE WAS NOTED AS BATTETY LOW/DEAD. 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.

    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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2010 ALLEGING A BATTERY INDICATOR ON HIS ONE TOUCH ULTRA METER. THE PATIENT MENTIONED THAT ALLEGED ISSUE WITH THE METER BEGAN APPROXIMATELY 2 MONTHS AGO. DUE TO THE ALLEGED ISSUE THE PATIENT DID NOT TAKE ANY ACTION. A FEW DAYS AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF FEELING WEAK, HAD VISION PROBLEMS AND HAD A HEADACHE. AT AN UNSPECIFIED TIME AFTER THE SYMPTOMS BEGAN, THE PATIENT WENT TO THE ER AND WAS ADMITTED IN THE HOSPITAL FOR 2 DAYS WITH AN INITIAL READING OF 27 MMOL/L (486 MG/DL). THE PATIENT WAS TREATED WITH INSULIN WHILE HIS STAY IN THE HOSPITAL. WHILE TROUBLESHOOTING, IT WAS NOTED THAT THERE WAS NO MISUSE OF THE PRODUCT; HOWEVER, THE BATTERIES NEEDED TO BE REPLACED. THE PATIENT DID NOT HAVE REPLACEMENT BATTERIES AT THE TIME OF THE INITIAL CALL. PRODUCTS WERE REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE BATTERY INDICATOR ON HIS METER, HE WAS UNABLE TO TEST, DEVELOPED SYMPTOMS AND HAD TO BE ADMITTED IN THE HOSPITAL FOR 2 DAYS FOR BLOOD GLUCOSE OF 27 MMOL/L.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R