BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANCED D-DIMER

    MDR report key: 557632 · Received December 1, 2004

    Report

    Report Number
    9610806-2004-00035
    Event Type
    Death
    Date Received
    December 1, 2004
    Date of Event
    September 20, 2004
    Report Date
    November 29, 2004
    Manufacturer
    DADE BEHRING GMBH
    Product Code
    DAP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT SAMPLE RESULTS FOR D-DIMER WERE REPORTED AS 0.0 MG/L BASED ON A DILUTED SAMPLE RESULT BELOW ASSAY MEASURING RANGE, LACKING ACCEPTABLE QC DATA FOR 2 LEVELS. 9/2004 - PT HAD FOOT SURGERY. 9 DAYS LATER - PT PRESENTED TO PHYSICIAN IN MILD DISTRESS COMPLAINING OF SHORTNESS OF BREATH FOR PAST 2 DAYS, PLEURITIC TYPE PAIN ON RIGHT SIDE AND INTERMITTENT LEFT ARM NUMBNESS. TREATED WITH AMI PROTOCOL TO RULE OUT MI/PULMONARY EMBOLUS. D-DIMER RESULT FLAGGED WITH RANGE OVER ERROR, DILUTED 1:8 AND REPEATED. DILUTED RESULT WAS BELOW ASSAY MEASURING RANGE AND REPORTED TO PHYSICIAN AS 0.8 MG/L EVEN THOUGH QC RESULTS FOR ONLY 1 LEVEL WERE ACCEPTABLE. PT DIAGNOSED WITH PROBABLE PNEUMONIA. LATER NEXT DAY - PT RETURNED WITH MORE SEVERE SYMPTOMS. CT SCAN DONE TO RULE OUT PULMONARY EMBOLUS AND ABDOMINAL AORTIC ANEURYSM. D-DIMER RESULT AGAIN WAS FLAGGED WITH RANGE OVER ERROR, DILUTED 1:8. RESULT FOR DILUTED SAMPLE WAS 20 MG/DL. PT HAD MASSIVE PULMONARY EMBOLUS WITH COR PULMONALE, CARDIAC ARREST, AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED D-DIMER FIBRIN, FIBRINOGEN SPLIT PRODUCTS ASSAY DAP DADE BEHRING GMBH NA 544540

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| O