BEUDAMED
    FDA Adverse Event Death Summary report: N

    COULTER MAXM A/L

    MDR report key: 72808 · Received February 27, 1997

    Report

    Report Number
    1023939-1997-00001
    Event Type
    Death
    Date Received
    February 27, 1997
    Date of Event
    January 29, 1997
    Report Date
    January 30, 1997
    Manufacturer
    INSTRUMENTS DIV. COULTER CORP.
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON HER FOLLOW-UP APPOINTMENT, AN ELDERLY PATIENT COLLAPSED AND DIED IN THE HOSPITAL. ON THE DAY OF THE INCIDENT, THE PATIENT'S BLOOD TEST RESULTS GENERATED A "PARTIAL ASPIRATION" ERROR, PRESUMABLY DUE TO A VERY LOW HEMOGLOBIN CONDITION. THE CUTOMER COMPLAINED THAT THESE "FLAGGED" RESULTS WERE NOT TRANSMITTED TO THE HOST COMPUTER. THIS IS PER THE INSTRUMENT DESIGN, INTENDED TO ASSURE REVIEW BY A HEALTH CARE PROFESSIONAL PRIOR TO BEING REPORTED OUT OF THE LABORATORY. THE SAMPLE IN QUESTION WAS NOT TREATED EITHER AS URGENT OR AS AN EMERGENCY SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER MAXM A/L AUTOMATED DIFFERENTIAL CELL COUNTER GKZ INSTRUMENTS DIV. COULTER CORP. 0156 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death