BEUDAMED
    FDA Adverse Event Death Summary report: N

    DADE DIMERTEST LATEX ASSAY

    MDR report key: 880437 · Received July 12, 2007

    Report

    Report Number
    9610806-2007-00007
    Event Type
    Death
    Date Received
    July 12, 2007
    Date of Event
    May 2, 2004
    Report Date
    June 27, 2007
    Manufacturer
    DADE BEHRING GMBH
    Product Code
    DAP
    PMA / PMN Number
    K974596
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT WAS REPORTED TO DADE BEHRING ON 6/26/07. BECAUSE OF THE AMOUNT OF LAPSED TIME FROM THE OCCURRENCE OF THE EVENT TO REPORTING TO DADE BEHRING (3 + YEARS), EVALUATION OF THE DEVICE IS NOT POSSIBLE. THE CAUSE FOR THE NEGATIVE D-DIMER RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    A NEGATIVE D-DIMER WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS IN THE EMERGENCY ROOM AND WAS OBSERVED FOR 12 HOURS BEFORE BEING TRANSFERRED TO AN ALTERNATE FACILITY. A CT SCAN WAS PERFORMED AT THIS FACILITY AND A PULMONARY EMBOLISM WAS DIAGNOSED. THE PATIENT EXPIRED IN 2004. THE INCIDENT WAS REPORTED TO DADE BEHRING ON 6/26/07.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DADE DIMERTEST LATEX ASSAY NA DAP DADE BEHRING GMBH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death