BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1917173 · Received December 8, 2010

    Report

    Report Number
    2939301-2010-10622
    Event Type
    Injury
    Date Received
    December 8, 2010
    Report Date
    November 16, 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. 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 HER ONE TOUCH ULTRA METER DOES NOT POWER ON. THE ALLEGED ISSUE WITH THE METER BEGAN ON (B)(6), 2010 AT 10:00AM. PRIOR TO TESTING, THE PATIENT DEVELOPED SYMPTOMS OF FEELING DIZZY, TIRED AND EXPERIENCED A HEADACHE. SHE ATTEMPTED TO TEST AND THE METER WOULD NOT POWER ON. SHE THEN WENT TO THE ER AND WAS TESTED ON THE ER METER AND OBTAINED A RESULT OF 400 MG/DL AND WAS TREATED WITH 15 UNITS OF REGULAR INSULIN. THE METER DID NOT POWER ON BY PRESSING THE POWER BUTTON AND THE PATIENT WAS USING THE CORRECT TEST STRIPS. WHILE TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT HAD NOT REPLACED THE BATTERY IN 2 YEARS. PATIENT DID NOT HAVE REPLACEMENT BATTERIES WITH HER AT THE TIME OF THE INITIAL CALL. CUSTOMER CARE ADVOCATE (CCA) ADVISED THE PATIENT TO REPLACE THE BATTERY. METER WAS NOT REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE AND WENT TO THE ER AND WAS TREATED FOR A BLOOD GLUCOSE IN THE ER OF 400 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2997570

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R