BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 687138 · Received March 7, 2006

    Report

    Report Number
    2939301-2006-00365
    Event Type
    Death
    Date Received
    March 7, 2006
    Date of Event
    February 25, 2006
    Report Date
    February 25, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON FEBRUARY 25, 2006, THE LAY PATIENT CONTACTED LIFESCAN ALLEGING THAT HER ONE TOUCH ULTRA METER WAS PROMPTING THE APPLY SAMPLE MESSAGE. THE MEDICAL AFFAIRS SPECIALIST SENT A LETTER TO THE PATIENT SINCE SHE COULD NOT BE REACHED VIA PHONE. THE PATIENT WAS UNABLE TO OBTAIN A RESULT ON THE REPORTED METER WHILE FEELING DIZZY, HAVING STOMACH CRAMPS, AND VOMITING. INFORMATION WAS NOT PROVIDED AS TO HOW LONG THE PATIENT HAD BEEN UNABLE TO TEST WITH THE METER. SHE WAS TAKEN TO THE HOSPITAL WHERE A RESULT WAS OBTAINED ON A HOSPITAL METER; THE RESULT OBTAINED WAS NOT PROVIDED. THE PATIENT WAS TREATED WITH AN INJECTION OF INSULIN. THE CUSTOMER SERVICE AGENT (CSA) WALKED THE PATIENT THROUGH ATTEMPTING TO TEST USING A NEW TEST STRIP AND ANOTHER TEST STRIP FROM A NEW VIAL OF TEST STRIPS; THE TEST DID NOT START WITH EITHER ATTEMPT. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT BECAUSE THE PATIENT EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA AND WAS UNABLE TO TEST WITH THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2587417

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R