BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS-2000I

    MDR report key: 10219658 · Received July 1, 2020

    Report

    Report Number
    1000515253-2020-00019
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    April 21, 2020
    Report Date
    July 1, 2020
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    K151259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION DETERMINED THE SYSMEX SERVICE ENGINEER (SE) APPLIED ERRONEOUS INTEGER AND DECIMAL SETTINGS FOR THE USER'S D-DIMER ASSAY. THE USER'S D-DIMER ASSAY WAS SET ORIGINALLY TO OUTPUT RESULT VALUES CONSISTING OF AN INTEGER OF 3 DIGITS AND A DECIMAL OF 2 DIGITS. THE SE APPLIED AN INCORRECT OUTPUT INTEGER SETTING OF 4 DIGITS AND AN INCORRECT OUTPUT DECIMAL OF 1 DIGIT. D-DIMER RESULT VALUES DISPLAYED CORRECTLY ON THE ANALYZER BUT TRANSMITTED TO THE LABORATORY INFORMATION SYSTEM (LIS) AS ONE-TENTH (1/10) OF THE ACTUAL MEASURED VALUE. A SERVICE ENGINEER CORRECTED THE INTEGER AND DECIMAL SETTINGS ON (B)(6) 2020.

    Description of Event or Problem · 1

    THE USER IN (B)(6) REPORTED LIXIANA (ORAL ANTICOAGULANT) ADMINISTRATION WAS DISCONTINUED PREMATURELY FOR ONE PATIENT DUE TO AN ERRONEOUS LOW REPORTED D-DIMER RESULT ON (B)(6) 2020. THE PATIENT WAS DISCHARGED ON (B)(6) 2020. THERE WAS NO REPORTED HARM TO THE PATIENT DUE TO THE PREMATURE DISCONTINUATION OF LIXIANA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683095 CS-2000I AUTOMATED BLOOD COAGULATION ANALYZER JPA SYSMEX CORPORATION CS-2000I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other