BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX CA-620

    MDR report key: 6912819 · Received October 3, 2017

    Report

    Report Number
    1000515253-2017-00034
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    August 9, 2017
    Report Date
    October 3, 2017
    Manufacturer
    SYSMEX RA CO. LTD.
    Product Code
    GKP
    PMA / PMN Number
    K031377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE TUBE (BD 1.8ML DOUBLE WALLED TUBE) USED FOR ANALYSIS WAS UNACCEPTABLE FOR USE ON THE ANALYZER. THE SAMPLE PROBE WAS HITTING THE SIDE OF THE TUBE WHILE ASPIRATING. NO ANALYZER DEFICIENCIES WERE IDENTIFIED. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE ANALYZER, THE ONLY DOUBLE WALLED TUBES TO BE USED ON THE ANALYZER ARE THE VACUTAINER PLUS PLASTIC CITRATE TUBE, 2.7 ML OR THE VACUETTE SANDWICH COAGULATION TUBE, 3.0 ML/3.5ML. THE IFU SPECIFICALLY IDENTIFIES THE TUBE USED AS NOT BEING ACCEPTABLE FOR USE ON THE ANALYZER.

    Description of Event or Problem · 1

    A SAMPLE WAS COLLECTED FROM A PATIENT RECEIVING COUMADIN TREATMENT IN AN UNAPPROVED SAMPLE COLLECTION TUBE. THE USER PERFORMED ANALYSIS WITH THE UNAPPROVED TUBE. THE INITIAL PROTHROMBIN TIME (PT) RESULT WAS "NO COAG", MEANING NO CLOT WAS FORMED AND NO RESULTS COULD BE GENERATED. THE NEXT ANALYSIS WAS A PROTHROMBIN TIME EXTENDED (PTX) WHICH ALSO RESULTED AS "NO COAG". THE PTX WAS REPEATED AND GAVE A RESULT OF 159.4 SECONDS. THIS RESULT WAS REPORTED TO THE CLINICIAN. THE CLINICIAN ADMINISTERED VITAMIN K TO THE PATIENT. THE ENTIRE CLINICAL PICTURE FOR THE PATIENT IS UNKNOWN. THE PATIENT WAS REDRAWN SEVERAL DAYS LATER AND RETURNED A PT RESULT OF 25.6 SECONDS WHICH CORRELATES WITH THE PATIENT'S CLINICAL PICTURE. THE USER REPORTED THIS VALUE IN A CORRECTED REPORT OF THE INITIAL VALUE. THE PATIENT DID NOT SUFFER ANY HARM DUE TO THE VITAMIN K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690773 SYSMEX CA-620 AUTOMATED BLOOD COAGULATION ANALYZER GKP SYSMEX RA CO. LTD. CA-620

    Patients

    Seq Age Sex Outcome Treatment
    1 Other