BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2192370 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06906
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    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 PATIENT'S PRODUCT HAS BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER REVERTED TO THE SETTINGS MODE WHEN ATTEMPTING TO TEST HER BLOOD GLUCOSE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON (B)(6) 2011 AT 2:15 PM. THE PATIENT STATED THAT SHE DOES NOT TAKE ANY MEDICATION TO MANAGE HER DIABETES. THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT DUE TO THE ALLEGED ISSUE. APPROXIMATELY 4 MINUTES AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT REPORTEDLY DEVELOPED SHAKY HANDS. THE PATIENT CLAIMED THAT THERE WAS NO TREATMENT PROVIDED DUE TO THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE ALLEGED ISSUE WAS RESOLVED WITH PROPER INSTRUCTION. THE PATIENT'S PRODUCT HAS BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3112698

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening