BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX CA-660

    MDR report key: 5760163 · Received June 29, 2016

    Report

    Report Number
    1000515253-2016-00016
    Event Type
    Injury
    Date Received
    June 29, 2016
    Date of Event
    May 17, 2016
    Report Date
    June 14, 2016
    Manufacturer
    SYSMEX CORPORATION
    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

    PER CA SCIENTIFIC BULLETIN THAT THE CUSTOMER RECEIVES UPON INSTALLATION OF THE ANALYZER, WHEN A "NO COAGULATION-ERROR 32" IS GENERATED THE OPERATOR SHOULD CHECK SAMPLE INTEGRITY, DELIVERY OF SAMPLE AND REAGENT, AND REANALYZE THE SAMPLE. IF THE ERROR PERSISTS, OPERATOR SHOULD USE ALTERNATE METHOD TO CONFIRM DATA. THE OPERATOR IS CAUTIONED DO NO REPORT RESULTS WITHOUT NUMERICAL VALUES. THE OPERATOR INTERPRETED THE ERROR MESSAGE INCORRECTLY. THE APTT VALUE WAS BEING USED BY THE PHYSICIAN TO DOSE ANTICOAGULANT THERAPY. NORMAL APTT RANGE IS TYPICALLY 28-38 SECONDS. ON HEPARIN THERAPY THE APTT ELEVATES TO BETWEEN 70 AND 120 SECONDS. MOST HOSPITAL PHARMACIES AND CLINICAL HEMATOLOGY SERVICES WILL HAVE SPECIFIC APTT GOALS DETERMINED IN THEIR SPECIFIC TREATMENT PROTOCOLS. SPECIFIC HEPARIN THERAPEUTIC RANGE FOR THE OPERATOR'S FACILITY IS MONITORED AND MAINTAINED BY THE HOSPITAL PHARMACY. THIS ISSUE WILL BE REPORTED ON THE BASIS THAT INCORRECT RESULTS LED TO A PATIENT RECEIVING INCREASED HEPARIN ADMINISTRATION, CARRYING WITH IT THE RISKS INVOLVED WITH RECEIVING HEPARIN: INCREASED RISK OF BLEEDING, HEMATOMA, PETECHIAL FORMATIONS, HEMORRHAGE, ETC. NO HARM TO THE PATIENT WAS INCURRED. NO EVIDENCE OF ANALYZER MALFUNCTION.

    Description of Event or Problem · 1

    A USER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS ON (B)(6) 2016 TO REPORT THE ANALYZER GENERATED A "NO COAGULATION ERROR 32" MESSAGE FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) ON MULTIPLE SAMPLES OF A SINGLE PATIENT. THE ISSUE WAS REPORTED TO SYSMEX AMERICA INC. (SAI) ON (B)(6) 2016. SAMPLE 1 WAS FROM A PATIENT ADMITTED TO THE HOSPITAL AND WAS ANALYZED ON (B)(6) 2016 AT 01:15 WITH AN APTT VALUE OF 20.7 SECONDS WITH NO ANALYSIS ERRORS. RESULTS WERE CONSIDERED ACCURATE AND REPORTED. THE PATIENT WAS ADMINISTERED 7,500 UNIT DOSE OF HEPARIN AND A 25,000 UNIT HEPARIN DRIP WAS STARTED. A NEW SAMPLE 2 WAS ANALYZED AT 19:25 ON (B)(6) 2016 WITH A APTT OF "NO COAGULATION ERROR 32" GENERATED. THE OPERATOR INCORRECTLY INTERPRETED THE RESULT AND REPORTED A VALUE OF <20 SECONDS. ON (B)(6) 2016, TWO NEW SAMPLES 3 AND 4 WERE ANALYZED AT 05:15 AND 11:35 WHICH GENERATED "NO COAGULATION ERROR 32." THE OPERATOR INCORRECTLY REPORTED APTT VALUE OF < 20 SECONDS ON BOTH SAMPLES. RESULTS WERE REPORTED TO THE PHYSICIAN. THE OPERATOR STATED THE PHYSICIAN QUESTIONED THE RESULTS AS THE PATIENT WAS RECEIVING INCREASED DOSAGES OF HEPARIN. THE OPERATOR SENT A NEW SAMPLE 6 TO A NEARBY LABORATORY WHICH GENERATED RESULTS OF >150.0 SECONDS FOR APTT. THE SAMPLE WAS SENT TO LAB CORP LABORATORY AND AN APTT RESULT OF "NO CLOT DETECTED" WAS GENERATED. QUALITY CONTROL (QC) RESULTS THAT WERE GENERATED BEFORE AND AFTER THE EVENT WERE WITHIN THE FACILITIES ACCEPTABLE RANGES, SPECIFIC DATA PRINTOUTS WERE NOT PROVIDED. THE OPERATOR STATED THE PATIENT WAS DISCHARGED WITHOUT ANY INDICATION OF A SERIOUS BLEEDING EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414454 SYSMEX CA-660 AUTOMATED BLOOD COAGULATION ANALYZER GKP SYSMEX CORPORATION CA-660

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other