BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX CA-660

    MDR report key: 6430649 · Received March 23, 2017

    Report

    Report Number
    1000515253-2017-00006
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    February 4, 2017
    Report Date
    March 23, 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

    QUALITY CONTROL WAS PERFORMED ON THE ANALYZER TWO HOURS PRIOR TO SAMPLE ANALYSIS AND WAS WITHIN ACCEPTABLE RANGES. THE DISCREPANT PATIENT RESULTS LED THE OPERATOR TO INVESTIGATE A POSSIBLE CLOG IN THE SAMPLE PROBE. THE PROBE WAS CLEANED WITH BLEACH AND RINSED SEVERAL TIMES AND THE INNOVIN REAGENT WAS REPLACED WITH A FRESH ALIQUOT. TWO OTHER SAMPLES WERE COLLECTED AND ANALYZED REPEATEDLY AND CONFIRMED ACCEPTABLE ANALYZER AND REAGENT PERFORMANCE. THERE WAS NO INDICATION OF A REAGENT PROBLEM AND NO MECHANICAL ERRORS OCCURRED DURING TESTING. A TRANSIENT INSTRUMENT ISSUE SUCH AS A CLOG IN THE PROBE, OR A SPECIFIC SAMPLE ISSUE SUCH AS IMPROPER COLLECTION OR HANDLING COULD NOT BE RULED OUT. NO INVESTIGATION NECESSARY.

    Description of Event or Problem · 1

    A PATIENT ARRIVED AT THE EMERGENCY ROOM WITH A NOSE BLEED. A BLOOD SPECIMEN WAS COLLECTED AND ANALYZED ON (B)(6) 2017 FOR A PROTHROMBIN TIME (PT) AND ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT). THE SAMPLE WAS REANALYZED DUE TO INITIAL RESULTS THAT WERE ABOVE THE THERAPEUTIC RANGE FOR PT. THE REPEAT PT DID NOT MATCH THE INITIAL ANALYSIS, BUT THE OPERATOR MISREAD THE RESULTS AND REPORTED THE INITIAL RESULT OUT OF THE LABORATORY IN ERROR. IT IS UNKNOWN WHY PTT WAS NOT REPEATED. THE PHYSICIAN TREATED THE PATIENT WITH ORAL VITAMIN K BASED ON THE FALSELY ELEVATED PT RESULT. THE ENTIRE CLINICAL PICTURE FOR THE PATIENT IS UNKNOWN. CORRECTED RESULTS WERE SUBSEQUENTLY REPORTED. THERE WAS NO HARM TO THE PATIENT WHO WAS DISCHARGED SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209019 SYSMEX CA-660 AUTOMATED BLOOD COAGULATION ANALYZER GKP SYSMEX RA CO., LTD. CA-660

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other