BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2061451 · Received April 18, 2011

    Report

    Report Number
    2939301-2011-03145
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 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

    (B)(6) 2011: THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 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 DOES NOT TURN ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 8:15AM. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED METER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM OF TREMBLING AND FELT NERVOUS FIFTEEN MINUTES LATER. THE PATIENT, HOWEVER, DENIED SHE RECEIVED ANY MEDICAL INTERVENTION FOLLOWING THE REPORTED POWER ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE (CSR) NOTED THAT THE SUBJECT METER'S BATTERIES DID NOT NEED TO BE REPLACED (PER OWNER'S BOOKLET RECOMMENDATION), THERE WAS NO MISUSE OF THE LFS PRODUCT, AND THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening