BEUDAMED
    FDA Adverse Event Death Summary report: N

    CS-2500

    MDR report key: 19827370 · Received July 25, 2024

    Report

    Report Number
    1000515253-2024-00006
    Event Type
    Death
    Date Received
    July 25, 2024
    Date of Event
    June 24, 2024
    Report Date
    July 25, 2024
    Manufacturer
    SYSMEX CORPORATION, I SQUARE
    Product Code
    JPA
    UDI-DI
    04987562433735
    PMA / PMN Number
    K172286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) CONTACTED SYSMEX AMERICA INC. (SAI) ON JUNE 28TH, 2024, WITH A REPORT OF A USER IN GERMANY MISINTERPRETING THE ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) COAGULATION CURVE GENERATED BY CS-2500 AUTOMATED COAGULATION ANALYZER. ERRONEOUS RESULTS WERE REPORTED AND INCORRECT TREATMENT, HEPARIN, WAS ADMINISTERED DUE TO THE ERRONEOUS RESULTS. THE FOLLOWING DATA WAS PROVIDED FOR INVESTIGATION: THE ANALYZER DID NOT GIVE A NUMERIC RESULT VALUE. INSTEAD, THE FOLLOWING ERROR WAS GENERATED: DH 0 - NO COAGULATION. DESPITE THE "NO COAGULATION" ERROR MESSAGE, THE USER REVIEWED THE COAGULATION CURVE AND DETERMINED A CLOTTING TIME BASED ON THE USER'S INTERPRETATION OF THE GRAPH. THE USER REPORTED AN APTT RESULT OF 53 SECONDS. ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT TWO ADDITIONAL SAMPLE RESULTS WERE MISINTERPRETED IN THE SAME MANNER WITH ERRONEOUS LOW APTT RESULTS REPORTED AND HEPARIN ADMINISTERED IN ERROR. ON 7/16/2024 ADDITIONAL INFORMATION WAS PROVIDED BY SIEMENS THAT THE PATIENT HAD EXPIRED ON (B)(6) 2024. THE SYSMEX AUTOMATED BLOOD COAGULATION ANALYZER CS-2500 IS A FULLY AUTOMATED BLOOD COAGULATION ANALYZER INTENDED FOR IN VITRO DIAGNOSTIC USE USING PLASMA COLLECTED FROM VENOUS BLOOD SAMPLES IN 3.2 % SODIUM CITRATE TUBES TO ANALYZE CLOTTING, CHROMOGENIC AND IMMUNOASSAY METHODS IN THE CLINICAL LABORATORY. THE CS-2500 INSTRUCTIONS FOR USE (IFU) CHAPTER 2 - PRINCIPLES OF OPERATION, SECTION 2.1 - SYSTEM OVERVIEW, CAUTIONS THE USER: "RESULTS SHOULD ALWAYS BE EVALUATED IN CONJUNCTION WITH CLINICAL AND OTHER LABORATORY FINDINGS." CHAPTER 8 SECTION 8.5.2 ANALYSIS DATA ERRORS, EXPLAINS "NO COAGULATION" MESSAGE - THE COAGULATION REACTION WAS NOT DETECTABLE, DUE TO LOW FIBRINOGEN CONCENTRATION, AN ANTICOAGULANT SAMPLE OR A REAGENT PROBLEM. IT DIRECTS THE USER TO: "REANALYZE AND MAKE A COMPREHENSIVE JUDGMENT, TAKING SAMPLE AND REAGENT, ETC. INTO CONSIDERATION. ALSO, SET A LONGER DETECTION TIME AND REPEAT THE ANALYSIS." THE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE USER ERROR DUE TO MISINTERPRETATION OF ANALYZER DATA OUTPUT. THIS EVENT IS BEING REPORTED DUE TO UNNECESSARY ADMINISTRATION OF HEPARIN LEADING TO COMPLICATIONS THAT CULMINATED IN THE PATIENT'S DEATH.

    Description of Event or Problem · 0

    AN OPERATOR MISINTERPRETED THE ACTIVATED PARTIAL THROMBOPLASTIN TIME COAGULATION CURVE GENERATED BY THE ANALYZER. ERRONEOUS RESULTS WERE REPORTED. PATIENT RECEIVED UNNECESSARY HEPARIN TREATMENT AND EXPIRED DUE TO CONSEQUENCES OF INTERNAL BLEEDING AND OTHER CLINICAL SIGNS AND SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302964 CS-2500 AUTOMATED BLOOD COAGULATION ANALYZER JPA SYSMEX CORPORATION, I SQUARE 04987562433735

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female Death