BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX CA-660 ANALYZER

    MDR report key: 3908562 · Received June 16, 2014

    Report

    Report Number
    3009711478-2014-00014
    Event Type
    Other
    Date Received
    June 16, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 9, 2014
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKP
    PMA / PMN Number
    K031377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATED THE CA-660 ANALYZER. FSE VERIFIED ALL ALIGNMENT, PERFORMED OPTICS CALIBRATION AND VERIFIED TEMPERATURES TO BE CORRECT. FSE VERIFIED ANALYZER TO BE OPERATIONAL. SYSMEX CA-600 SERIES (INCLUDES CA-660), SYSTEM OPERATOR'S MANUAL, CHAPTER 14 - TROUBLESHOOTING EXPLAINS EACH OF THE ERRORS THAT CAN OCCUR. THE "NO COAGULATION" ERR032 STATES THAT THE ERROR OCCURS WHEN COAGULATION IS NOT DETECTED. CORRECTIVE ACTION INSTRUCTS THE OPERATOR MAKE COMPREHENSIVE JUDGMENT, TAKING VARIOUS ASPECTS INTO CONSIDERATION, INCLUDING WHETHER OR NOT ANY ERROR IS INVOLVED IN SAMPLES (STORAGE STATUS, BLOOD COLLECTING PROCEDURE, ETC.) AND REAGENTS. THE SYSMEX CA SERIES MEASUREMENT EVALUATION AND CHECK METHODS SCIENTIFIC BULLETIN, WHICH IS PROVIDED TO USERS, STATES THAT IF ERROR 32 PERSISTS ON REANALYSIS OF THE SAMPLE USE AN ALTERNATE METHOD TO CONFIRM THE DATA AND NOT TO REPORT RESULTS WITHOUT NUMERICAL VALUES. THE SAMPLE TUBE CANNOT BE RULED OUT AS A CAUSE OF ERROR 32 "NO COAGULATION." BECTON DICKINSON (BD) 1.8 ML TUBES WERE USED FOR BLOOD COLLECTION. INCOMPLETE SAMPLE ASPIRATION CAN OCCUR WITH TUBES ON THIS ANALYZER. THE INNER DIAMETER IS LESS THAN SPECIFIED FOR USE ON THE CA-660. SYSMEX CA-600 SERIES SYSTEM OPERATOR'S MANUAL, CHAPTER 5 - OPERATIONS, LISTS THE ACCEPTABLE COLLECTION TUBES THAT ARE COMPATIBLE WITH THE ANALYZERS. THE RECOMMENDATION SPECIFICALLY STATES THAT THE LIST DOES NOT INCLUDE VACUTAINER PLUS PLASTIC CITRATE TUBE 1.8 ML (BECTON DICKINSON). THE USER WAS EDUCATED ON THE APPROPRIATE TUBES REQUIRED FOR BLOOD COLLECTIONS.

    Description of Event or Problem · 1

    THE USER OF A CA-660 AUTOMATED BLOOD COAGULATION ANALYZER CONTACTED SIEMENS HEALTHCARE DIAGNOSTIC TO REPORT THAT RESULTS OF ">100 SECONDS" FOR PROTHROMBIN TIME (PT) WAS REPORTED OUT OF THE LAB ON TWO OCCASIONS, RESULTING IN THE PATIENT RECEIVING UNNECESSARY TREATMENT OF ORAL VITAMIN K, IN THE EMERGENCY ROOM (ER). THE PATIENT DIAGNOSED WITH ATRIAL FIBRILLATION, WAS ON COUMADIN THERAPY. (B)(6) A SAMPLE WAS DRAWN TO ASSESS THE EFFICACY OF THERAPY. A SAMPLE ANALYSIS ERROR 32 "NO COAGULATION" WAS GENERATED; NO NUMERICAL VALUE WAS DETERMINED BY THE ANALYZER. THE OPERATOR REPORTED PT RESULT ">100 SECONDS" (THE UPPER END OF THE FACILITY'S REPORTABLE RANGE FOR PT). THE PATIENT WAS REDRAWN AND SAMPLE ANALYZED ON (B)(6) AND ANALYSIS ERROR 32 "NO COAGULATION" WAS OBTAINED AND RESULT ">100 SECONDS" WAS REPORTED A SECOND TIME. THE PATIENT WAS GIVEN AN ORAL TREATMENT OF VITAMIN K AT 10:00 AM IN THE EMERGENCY ROOM. THE EMERGENCY ROOM CHECKED PATIENT'S RESULTS USING A POINT OF CARE (POC) ANALYZER; MAKE AND MODEL ARE UNKNOWN. THE USER REPORTED THAT THE PATIENT WAS IN STABLE CONDITION PRIOR TO AND AFTER VITAMIN K TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353452 SYSMEX CA-660 ANALYZER AUTOMATED BLOOD COAGULATION ANALYZER GKP SYSMEX CORPORATION CA-660

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other