BEUDAMED
    FDA Adverse Event Death Summary report: N

    COAG-A-MATE MTX COAGULATION ANALYZER

    MDR report key: 255776 · Received December 21, 1999

    Report

    Report Number
    1039284-1999-00002
    Event Type
    Death
    Date Received
    December 21, 1999
    Date of Event
    November 22, 1999
    Report Date
    December 14, 1999
    Manufacturer
    ORGANON TEKNIKA CORP.
    Product Code
    GKP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LAB TECHNICIAN RAN A PT BLOOD SAMPLE FOR A PTT ON THE MTX ANALYZER. THE MTX REPORTED A PTT OF 12.19 SEC WITH "RNG!" ERROR MESSAGE. REPEATED AND THE MTX REPORTED 20.5 SEC, AND REPEATED AGAIN AND GOT 28.4 SEC. TECH REPORTED THE 20.5 RESULT TO THE PHYSICIAN. THE PT WAS GIVEN A BOOST OF HEPARIN. LATER, THE PT EXPERIENCED A CRANIAL BLEED, AND SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAG-A-MATE MTX COAGULATION ANALYZER COAGULATION INSTRUMENT GKP ORGANON TEKNIKA CORP. 00381 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death 1. HEPARIN THERAPY (11/14/1999 TO 11/23/1999).