BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXTER Z II

    MDR report key: 678286 · Received February 20, 2006

    Report

    Report Number
    1826988-2006-00093
    Event Type
    Death
    Date Received
    February 20, 2006
    Date of Event
    January 29, 2006
    Report Date
    January 29, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A DIABETIC PT ATTEMPTED SUICIDE BY TAKING AN ORGANIC PHOSPHOROUS INSECTICIDE. SHE WAS ADMITTED TO THE HOSPITAL IN JANUARY 2006 AND WAS GIVE PAM (PRALIDOXINE METHIODIDE) AS AN ANTIDOTE. PAM WAS ADMINISTERED UNTIL 8:00 AM IN 2006. THE PT WAS IN CHRONIC RENAL FAILURE AND WAS GIVEN CONTINUOUS HEMODIAFILTRATION (CHDF). THE CHDF WAS ADMINISTERED WITHIN FOUR DAYS FIRST. CHDF WAS INTERRUPTED IN 2006. THE PT'S FIRST BLOOD GLUCOSE SAMPLE WAS 265 MG/DL. THIS WAS TAKEN IMMEDIATELY WITH THE LABORATORY INSTRUMENT IMMEDIATELY AFTER SHE WAS ADMITTED. IN 2006, THE PT'S BLOOD WAS TESTED USING BOTH THE DEXTER-Z II METER AND THE LABORATORY METER. TESTING ON BOTH METERS WAS DONE AT THE SAME TIME AND BY THE SAME SAMPLE. TESTING WAS PERFORMED USING ARTERIAL BLOOD. RESULTS WERE INCONSISTENT BETWEEN THE LABORATORY METER AND THE DEXTER-Z II METER. THE PT WAS GIVEN INSULIN FOR SEVEN DAYS. THE PT DIED AT 12:40 AM IN 1/2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTER Z II BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 3958C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death