BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLUCOMETER ELITE 4 BASIC

    MDR report key: 531982 · Received June 25, 2004

    Report

    Report Number
    1810909-2004-00196
    Event Type
    Death
    Date Received
    June 25, 2004
    Date of Event
    May 21, 2000
    Report Date
    June 21, 2004
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT FOUR YEARS AGO (DATE IS AN APPROXIMATION) A DECEASED PT (CARDIAC ARREST) WAS TESTED WITH AN ELITE BLOOD GLUCOSE METER WITH A VENOUS SAMPLE AND REC'D A RESULT OF 327MG/DL. THE LAB RESULTS LATER SHOWED A RESULT THAT WAS APPROX 300MG/DL HIGHER THAN THE ELITE'S READING TAKEN ON A VENOUS SAMPLE. THE INCIDENT HAPPENED 4 YEARS AGO AND IT IS UNKNOWN HOW LONG THE PT WAS DECEASED WHEN THE SAMPLE WAS TAKEN. THE SAMPLE WAS TAKEN DURING CPR AND AFTER AN IV HAD BEEN ADMINISTERED. THE PT WAS DECEASED PRIOR TO THE THE BLOOD GLUCOSE RESULTS AND WAS NOT REVIVED. THE CUSTOMER WAS REMINDED THAT THE ELITE METER IS NOT RECOMMENDED FOR USE IN THIS TYPE OF SITUATION - IN ACCORDANCE WITH THE PRODUCT INSERT. THIS COMPLAINT IS CONSIDERED CLOSED UNLESS FURTHER INFO BECOMES AVAILABLE - THE METER USED IS IDENTIFIED FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE 4 BASIC BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 3901N *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death