BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX CA-1500

    MDR report key: 5807685 · Received July 19, 2016

    Report

    Report Number
    1000515253-2016-00020
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    June 2, 2016
    Report Date
    June 23, 2016
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKP
    PMA / PMN Number
    K993299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ON JUNE 4, 2016 A SIEMENS FIELD SERVICE ENGINEER (FSE) CHECKED INR PRECISION WHICH PASSED. RESULT WAS 1.2 CV FOR INR (LESS THAN 2.0 CV IS WITHIN SPECIFICATION). THE ANALYZER TESTED OPERATIONAL. THE FSE REPLACED THE SAMPLE PROBE AND REALIGNED. TUBING WAS CHECKED NO EVIDENCE OF LEAKING WAS OBSERVED. THE FSE REMOVED AND REPLACED SYRINGES. THE REASON FOR PART REPLACEMENT WAS UNKNOWN AND LIKELY DUE TO NORMAL WEAR. THE FSE PERFORMED PRECISION AFTER PART REPLACEMENT AND INR RESULT WAS 1.1 CV PASSING SPECIFICATION. ALL QC WAS ANALYZED AND WITHIN LABORATORY ESTABLISHED RANGES. ANALYZER TESTED OPERATIONAL. INVESTIGATION INTO A ROOT CAUSE IS ONGOING BY SYSMEX CORPORATION (B)(4). PRECISION AND QC DATA ALONG WITH FSE DOCUMENTATION DEMONSTRATES THERE WAS NO EVIDENCE OF ANALYZER MALFUNCTION. IT IS POSSIBLE IMPROPER COLLECTION AND/OR SAMPLE INTEGRITY CONTRIBUTED TO THE EVENT. THIS EVENT WILL BE REPORTED ON THE BASIS THAT A POST PROCEDURAL BLEED OCCURED. THE SURGICAL PROCEDURE WAS PERFORMED AFTER OBTAINING AN INITIAL PT AND INR THAT WAS ABOVE THE NORMAL RANGE, CARRYING WITH IT THE RISKS INVOLVED: BLEEDING EPISODES AND THROMBOSIS. THE PATIENT WAS DISCHARGED TO THE GENERAL WARD AFTER TREATMENT IN THE ICU. THERE WAS NO REPORT OF PERMANENT INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    THE USER OF THE ANALYZER IS IN (B)(6) WHO CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS ON (B)(6) 2016 AFTER EXPERIENCING ERRONEOUS LOW PROTHROMBIN (PT) AND INTERNATIONAL NORMALIZED RATIO (INR). THE ISSUE WAS REPORTED TO SYSMEX CORPORATION (B)(4) AND SYSMEX AMERICA, INC. (SAI) ON JUNE 23, 2016. THE USER REPORTED THE ISSUE OCCURRED OVER A 24 HOUR PERIOD FOLLOWING PREVENTATIVE MAINTENANCE. THE EVENT OCCURRED ON (B)(6) 2016. QUALITY CONTROL VALUES WERE WITHIN SPECIFIED RANGES DURING THE TIME OF THE OCCURRENCE. THE OPERATOR ANALYZED THE PATIENT SAMPLE WHICH GENERATED A SLIGHTLY INCREASED INR VALUE. THE FACILITY'S NORMAL REFERENCE RANGE FOR PT IS 10.0-14.0 SECONDS AND INR IS 0.8-1.2. A PLANNED PERICARDIAL EFFUSION PROCEDURE WAS PERFORMED ON THE WARD. THE PATIENT SUFFERED A POST-PROCEDURAL BLEED AND WAS SENT TO THE ICU WHERE HE REMAINED FOR 5 DAYS THEN DISCHARGED TO A GENERAL WARD. AFTER THE PROCEDURE A SECOND SAMPLE WAS COLLECTED AND ANALYZED THE FOLLOWING DAY DEMONSTRATING A PROLONGED INR RESULT. NO ANALYZER DATA WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460472 SYSMEX CA-1500 AUTOMATED COAGULATION ANALYZER GKP SYSMEX CORPORATION CA-1500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other