BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE TOUCH II

    MDR report key: 280125 · Received May 30, 2000

    Report

    Report Number
    2939301-2000-00442
    Event Type
    Death
    Date Received
    May 30, 2000
    Date of Event
    February 22, 2000
    Report Date
    April 24, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DECEASED, AN IDDM, OBTAINED "EXTREMELY LOW" RESULTS ON THE ONE TOUCH II METER OF 15, 22, 26, 59 MG/DL. BASED UPON THESE RESULTS, PT CEASED TAKING INSULIN FOR TWO DAYS. PT HAD BEEN VOMITING FOR TWO DAYS, UNABLE TO KEEP FLUIDS OR FOOD IN PT'S SYSTEM SINCE 02/21/2000 AT APPROX 5PM. PT WAS FOUND BY A FRIEND ON 02/22/2000 AT APPROX 5PM, UNCONSCIOUS AND UNRESPONSIVE. 911 WAS CALLED. NO VISIBLE SIGNS OF LIFE COULD BE FOUND. PT WAS PRONOUNCED DEAD AT 6:55PM. CAUSE OF DEATH: "A RESULT OF UNCONTROLLED DIABETES MELLITUS." THE AUTOPSY REPORT NOTED A BLOOD GLUCOSE OF OVER 900, KETONES, AND A POTASSIUM OF 15. ADD'L INFO WAS PROVIDED BY THE DECEASED'S PARENT. THE TEST STRIPS USED BY THE DECEASED (AND ALLEGEDLY PURCHASED ON 01/14/2000) WERE TESTED ON THE PARENT'S METER WITH A RESULT OF "20". THE PARENT THEN TESTED USING THEIR OWN STRIPS AND OBTAINED A RESULT OF "112". PARENT DENIED FEELING THE METER WAS RESPONSIBLE FOR THE DEATH, "OH, NO, IF ANYTHING IT WAS THE STRIPS." PARENT REPORTED THAT NO QUALITY CONTROL RESULTS COULD BE FOUND IN THE METER MEMORY. AT ONE POINT, THE DECEASED ALLEGEDLY PURCHASED A ONE TOUCH BASIC ENHANCED METER. HOWEVER, THE ONLY RESULTS NOTED IN THE METER MEMORY WERE A CHECK STRIP RESULT OF 88 (RANGE 73-98) AND A CONTROL SOLUTION RESULT OF 109. THERE IS NO ALLEGATION THAT THE PT EXPIRED AS A RESULT OF USE OF THE ONE TOUCH II METER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death