BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE TOUCH BASIC

    MDR report key: 278525 · Received May 19, 2000

    Report

    Report Number
    2939301-2000-00423
    Event Type
    Death
    Date Received
    May 19, 2000
    Date of Event
    February 17, 2000
    Report Date
    April 7, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE DECEASED'S DAUGHTER REPORTED THAT PRIOR TO FEBRUARY 15, THE DECEASED STOPPED TAKING THE ORAL MEDICATION ON THE OWN BASED UPON METER RESULTS. A FASTING MORNING RESULT ON 2/15 WAS 70MG/DL. PT WAS TAKEN TO SEE THE PHYSICIAN WHERE 1 HOUR LATER, THE DOCTOR'S METER WAS 298 OR 398MG/DL. PHYSICIAN RECOMMENDED PT PURCHASE A NEW METER, INCREASED THE GLYBURIDE FROM 5MG IN THE MORNING TO 5MG IN THE MORNING AND EVENING, AND TOLD PT TO BEGIN TAKING THE ORAL AGENT AGAIN. NO TREATMENT WAS PROVIDED. ON 02/17/2000, A TEST ON THE DECEASED'S ONE TOUCH BASIC METER WAS 92MG/DL. PT SAW THE PHYSICIAN COMPLAINING OF MINOR CHEST PAIN AND DRY COUGHING. A TEST AT THE OFFICE (UNKNOWN IF METER OR LAB) WAS 290MG/DL. THE DOCTOR INFORMED PT HAD A COLD AND THAT THERE WAS NOTHING WRONG WITH THE HEART. NO TREATMENT WAS PROVIDED. PT'S DAUGHTER PICKED PT UP AFTER THE APPOINTMENT AND TOOK PT HOME. DURING THIS TIME THE DECEASED COMPLAINED OF "NOT BREATHING." AN AMBULANCE, CALLED FROM THE HOME, ARRIVED 45 MINUTES LATER. IT WAS REPORTED THE PT DIED ENROUTE TO THE HOSP. THE DEATH CERTIFICATE LISTED CAUSE OF DEATH AS MASSIVE HEART ATTACK, DIABETES, HIGH BLOOD PRESSURE. THE METER IS CLEANED AFTER EACH USE WITH A DRY Q-TIP, THE TEST STRIP HOLDER HAD BEEN REMOVED ONLY ONCE FOR CLEANING. THE SAMPLE WAS REPORTED AS "WATERY, BLACK, FLAT AND DRY" AFTER TEST. THE METER WAS IN CALIBRATION ON 04/12/2000 READING 75 WITHIN A RANGE OF 68-90.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death