BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 553831 · Received November 3, 2004

    Report

    Report Number
    2939301-2004-05616
    Event Type
    Death
    Date Received
    November 3, 2004
    Date of Event
    October 24, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2004, THE PT'S FAMILY MEMBER CONTACTED LIFESCAN ON THE BEHALF OF PT ALLEGING THAT THE PT'S ONE TOUCH ULTRA METER WAS READING INACCURATELY. THE MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PT'S FAMILY MEMBER ON THE FOLLOWING DAY. THE PT HAD BEEN STAYING WITH THE FAMILY MEMBER FOR THE LAST TWO WEEKS. OVER THE LAST TWO WEEKS, THE FAMILY MEMBER NOTED THAT THE PT'S LEGS WERE BECOMING PROGRESSIVELY EDEMATOUS. THE PT TOLD THE FAMILY MEMBER THE READINGS HAD BEEN GOOD ON THE METER. THE FAMILY GLANCED AT THE METER DISPLAY QUICKLY ON A COUPLE OCCASIONS AND SAW RESULTS THAT APPEARED TO BE IN THE 140 MG/DL RANGE. AS THE PT ALSO HAS CHF, THE FAMILY MEMBER THOUGHT THE CHF MIGHT BE CAUSING INCREASED EDEMA. THE PT ROUTINELY TAKES LANTUS INSULIN 8 OR 9 UNITS EACH NIGHT AND SLIDING SCALE NOVOLOG INSULIN GIVEN BEFORE EACH MEAL DEPENDENT ON THE METER RESULTS. THE PT'S FAMILY MEMBER SAID THAT THE PT HAD NOT BEEN TAKING SLIDING SCALE INSULIN FOR SOME TIME BECAUSE THEY THOUGHT THAT THE BLOOD GLUCOSE READINGS WERE NORMAL OR CLOSE TO NORMAL. FOUR DAYS EARLIER, THE PT WAS FEELING WEAK. THE FAMILY MEMBER TESTED THEIR BLOOD GLUCOSE WITH REPORTED METER AND OBTAINED A RESULT OF 19.9 MMOL/L (CONVERTS TO 358 MG/DL) TWICE IN A ROW. THE FAMILY TESTED THE PT WITH ANOTHER METER AND OBTAINED A RESULT OF 405 MG/DL. THE FAMILY MEMBER GAVE THE PT NOVOLOG INSULIN 6 UNITS. THE FAMILY MEMBER CONTACTED LFS WHEN THEY NOTED THE DECIMAL POINT IN THE RESULT AND THE CUSTOMER SERVICE REPRESENTATIVE WALKED THEM THROUGH RESETTING THE METER TO MG/DL UNIT OF MEASUREMENT. THE PT WAS BECOMING WEAKER AND COULD BARELY GET TO THE BATHROOM WITH THE ASSASTANCE OF TWO PEOPLE. THE FAMILY MEMBER CALLED EMT DUE TO THE PT'S WORSENING CONDITION. PRIOR TO EMT'S ARRIVAL, THE FAMILY MEMBER OBTAINED A RESULT OF 193 MG/DL ON THE REPORTED METER. NO RESULT WAS OBTAINED ON THE EMT METER. AN IV WAS STARTED AND THE PT WAS TAKEN TO THE ER AND ADMITTED TO THE HOSPITAL. THE FAMILY MEMBER WAS NOT SURE WHAT RESULTS WERE OBTAINED IN THE HOSPITAL.

    Description of Event or Problem · 1

    SEE ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 1023788

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| H| L| R| S