BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 691948 · Received March 21, 2006

    Report

    Report Number
    2939301-2006-00443
    Event Type
    Injury
    Date Received
    March 21, 2006
    Report Date
    March 13, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2006 THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT SHE WAS UNABLE TO TEST DUE TO THE APPLY SAMPLE ISSUE. THE PATIENT REPORTED THAT THE METER WAS NOT OUT OF THE BOX. THE PATIENT WAS UNABLE TO TROUBLESHOOT WITH THE CUSTOMER CARE ADVOCATE BECAUSE SHE DID NOT HAVE ANY TEST STRIPS. ON AN UNSPECIFIED DATE/TIME, THE PT WAS NOT ABLOE TO GET A METER READING SO SHE CALLED HER DOCTOR. HER DOCTOR ADVISED HER TO GO TO A HOSPITAL. AT THE TIME OF TESTING, THE PATIENT WAS UNABLE/UNWILLING TO REPORT ANY SYMPTOMS. PRIOR TO RECEIVING ANY MEDICAL ATTENTION THE PTIENT HAD HER BREAKFAST. THREE HOURS AFTER THE ATTEMPTED TEST ON HER METER, HER BLOOD GLUCOSE WAS "165 MG/DL" ON THE HOSPITAL METER AND WAS GIVEN 10 UNITS R INSULIN AND 16 UNITS N INSULIN (UNKNOWN IF THIS WAS GIVEN TO TREAT ANY SYMPTOMS OR IF IT WAS BASED ON THE PATIENT'S REGIMEN). THE MEDICAL AFFAIRS SPECIALIST SENT A LETTER 4 DAYS LATER INCE THE PATIENT CANNOT BE REACHED BY TELEPHONE. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2594457

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R