BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX CA-1500

    MDR report key: 653744 · Received December 13, 2005

    Report

    Report Number
    1422681-2005-00001
    Event Type
    Malfunction
    Date Received
    December 13, 2005
    Date of Event
    May 18, 2005
    Report Date
    July 14, 2005
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    JPA
    Removal / Correction Number
    NOT REQUIRED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SYSMEX CA-1500 AUTOMATED COAGULATION ANALYZER USED OUTSIDE THE UNITED STATES, INCORRECTLY REPORTED A D-DIMER RESULT OF 0 UG/L DESPITE THE RAW DATA INDICATING A CONCENTRATION ABOVE THE CALIBRATION RANGE ON A PATIENT SAMPLE. UPON 1:8 DILUTION, THE CONCENTRATION WAS 1047 UG/L. THE INCORRECT RESULTS WERE NOT REPORTED TO THE PHYSICIAN, SO THERE WAS NO HARM TO THE PATIENT. THE INCIDENT WAS ORIGINALLY ATTRIBUTED TO THE D-DIMER PLUS REAGENTS USED IN THE FOREIGN COUNTRY BUT NOT DISTRIBUTED IN THE U.S. INVESTIGATION OF THE COMPLAINT BY SYSMEX CORPORATION REVEALED A LOW POSSIBILITY EXISTS THAT IF AN INVALID STANDARD CURVE IS CREATED WHEN THE AKIMA, OR AKIMA 0 (ZERO) METHOD FOR CURVE GENERATION IS USED, A VERY HIGH CONCENTRATION OF D-DIMER MEASURED FROM THE INVALID CURVE MAY BE SHOWN AS EITHER ZERO, OR A LOW VALUE.

    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 UNKNOWN Other