BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1964349 · Received January 19, 2011

    Report

    Report Number
    2939301-2011-00598
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 3, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-02/22/2011. THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE LCD CABLE/CABLE CONNECTOR FAILURE. 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

    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. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE DISPLAY ON HER ONETOUCH ULTRA WAS FADING AND HAD MISSING SEGMENTS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUES BEGAN ON (B)(6) 2010 AT 7AM. THE PATIENT MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS); HOWEVER, IT IS UNCLEAR WHAT ACTION, IF ANY, THE PATIENT TOOK IN RESPONSE TO THE ALLEGED METER ISSUE. THE PATIENT DENIED TESTING HER BLOOD GLUCOSE WITH ANOTHER DEVICE. AS A RESULT OF THE REPORTED DISPLAY ISSUES, THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS OF SHAKING AND SWEATING EIGHT HOURS LATER. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD AND/OR DRINK AT THE SAME TIME AFTER THE ONSET OF HER REPORTED SYMPTOMS AND THE PATIENT REPORTEDLY ALSO DECREASED THE DOSE OF HER NPH INSULIN BY 10 UNITS AT 3:15PM. AT THE TIME OF TROUBLESHOOTING, THE PATIENT DENIED ANY TRAUMA TO THE SUBJECT METER. 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3038667

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening