BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSMEX CA-1500

    MDR report key: 803669 · Received January 8, 2007

    Report

    Report Number
    1422681-2007-00001
    Event Type
    Death
    Date Received
    January 8, 2007
    Date of Event
    October 27, 2006
    Report Date
    January 5, 2007
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    k992423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SYSMEX CA-1500 AUTOMATED COAGULATION ANALYZER GENERATED A FALSELY LOW D-DIMER RESULT (< 0.43 MG/L) ON A PATIENT SAMPLE ANALYZED DIRECTLY FROM THE COLLECTION TUBE. REPEAT TESTING OF SAME SAMPLE AFTER BEING POURED INTO A SPECIMEN CUP YIELDED A RESULT OF 1.43 MG/L. QC LEVEL I AND QC LEVEL 2 PLASMA CONTROLS PERFORMED WITHIN SPECIFICATIONS. FOLLOWING A REAGENT EXCHANGE, THE PATIENT SPECIMEN WAS RE-RUN AND YIELDED A RESULT OF 9.77 MG/L. THE CUSTOMER ACCOUNT SUSPECTED A PROBLEM AND THE SAMPLE WAS SENT TO AN UNIDENTIFIED SITE FOR CONFIRMATION. A RESULT OF 167.3 UG/ML (167.3 MG/L) WAS OBTAINED AT THIS SITE USING A COMPETITOR'S ANALYZER. THE CUSTOMER INDICATED A DELAY IN TREATMENT OCCURRED SINCE THE SAMPLE HAD TO BE SENT OUT FOR CONFIRMATION OF RESULTS. THE DIFFERING D-DIMER RESULTS OBSERVED BETWEEN THE ORIGINAL COLLECTION TUBE AND THE SAMPLE CUP SUGGESTS POSSIBLE CLOTTED SAMPLE OR ASPIRATION OF FIBRIN STRANDS. THE REPORTING INSTITUTION, HOWEVER, INDICATED THEY SAW NO EVIDENCE OF A COMPROMISED PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX CA-1500 AUTOMATED COAGULATION ANALYZER JPA SYSMEX CORPORATION CA-1500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death