BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XT-4000I

    MDR report key: 11863359 · Received May 21, 2021

    Report

    Report Number
    1000515253-2021-00009
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 21, 2021
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K091313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL ANALYSES OF SAMPLE ID (B)(6) WERE JUDGED "POSITIVE" WITH IP MESSAGES ALERTING TO POSSIBLE SAMPLE ABNORMALITY. THE XT-4000I SOFTWARE GUIDE (SG), CHAPTER 6: APPENDIX, SECTION 6.1: IP MESSAGES, DETAILS THE METHOD IN WHICH THE ANALYZER CONVEYS ITS FINDINGS. RESULTS WITHOUT AN ERROR MESSAGE ARE CATEGORIZED AS "POSITIVE" OR "NEGATIVE" BASED UPON PRESET CRITERIA, SOME OF WHICH ARE LABORATORY-DEFINED. THE SYSTEM BASES ITS JUDGMENTS ON COMPREHENSIVE SURVEYS OF NUMERICAL DATA, PARTICLE SIZE DISTRIBUTIONS, AND SCATTERGRAMS. THE PURPOSE OF IP MESSAGE FLAGGING IS TO ALERT TO POSSIBLE SAMPLE ABNORMALITY. FURTHER VERIFICATION OF ACCURATE RESULTS IS RECOMMENDED PRIOR TO REPORTING TO THE CLINICIAN. THE LABORATORY FOLLOWED STANDARD OPERATING PROCEDURE BY CONFIRMING THE PLT RESULT. ALL REANALYSES OF SID (B)(6) GENERATED PLT RESULTS WITH AS ASTERISK [*]. CHAPTER 3: STORED SAMPLES (EXPLORER), SECTION 3.2: SAMPLE EXPLORER SCREEN DISPLAY, DESCRIBES THE MASKS AND MARKS THAT MAY BE ADDED TO ANALYSIS DATA. MASKS AND MARKS INDICATE AN ABNORMALITY IN THE ANALYSIS DATA. AN ASTERISK INDICATES DATA IS UNRELIABLE. FURTHER REVIEW OF THE SAMPLE IS NEEDED PRIOR TO RESULT REPORTING. THE LABORATORY APPROPRIATELY VERIFIED ALL RESULTS WITH AN ASTERISK. THE SAMPLES COLLECTED IN SODIUM CITRATE ANTICOAGULANT GENERATED PLT RESULTS WITH AN AMPERSAND [&]. SECTION 3.2: SAMPLE EXPLORER SCREEN DISPLAY, STATES THE AMPERSAND INDICATES THE DATA WAS CORRECTED DUE TO A PARTICULAR INTERFERENCE, OR A VALUE OBTAINED FROM ANOTHER ANALYSIS CHANNEL WAS USED. PLT& INDICATES THE OPTICAL PLT (PLT-O) WAS REPORTED BECAUSE THE IMPEDANCE PLT (PLT-I) WAS CONSIDERED TO BE UNRELIABLE. THE PRESENCE OF THE PALE PURPLE BACKGROUND AND ROULEAUX NOTED ON THE SMEARS INDICATES THE POSSIBLE PRESENCE OF CRYOGLOBULINS/CRYOPROTEINS. THE XT-4000I, INSTRUCTIONS FOR USE (IFU), CHAPTER 11: TECHNICAL INFORMATION, SECTION 11.2: POSSIBLE SAMPLE INTERFERENCES, INFORMS OF SITUATIONS WHERE RESULTS MAY BE AFFECTED. FOR PLTS, THE IFU NOTES: "IF ANY OF THE FOLLOWING IS PRESENT, THE SYSTEM MAY ERRONEOUSLY REPORT A HIGH PLATELET COUNT. MICROCYTOSIS, FRAGMENTED ERYTHROCYTES, FRAGMENTED LEUKOCYTES, CRYOPROTEIN, CRYOGLOBULIN." THE ANALYZER PERFORMED AS DESIGNED.

    Description of Event or Problem · 1

    A LABORATORY IN (B)(6) REPORTED INCONSISTENT PLATELET (PLT) RESULTS LED TO A DELAY IN TREATMENT AND/OR PATIENT CARE. THE SAMPLE FROM AN OUTPATIENT WAS ANALYZED AND JUDGED "POSITIVE" WITH AN INTERPRETIVE PROGRAM (IP) MESSAGE ALERTING THE USER TO SAMPLE ABNORMALITY. DUE TO THE IP MESSAGE, A SMEAR REVIEW WAS PERFORMED AND NO PLTS WERE OBSERVED. THE PLT RESULT WAS HELD FROM RELEASE. THE SAMPLE WAS ANALYZED SEVERAL MORE TIMES, GENERATING INCONSISTENT PLT RESULTS. ALL PLT RESULTS WERE HELD FROM RELEASE. SEVERAL SMEARS WERE PREPARED AND REVIEWED DEMONSTRATING CRITICALLY LOW PLT COUNTS WITH NO PLT CLUMPING. THE SMEARS WERE NOTED TO HAVE A PALE PURPLE BACKGROUND AND ROULEAUX. WHEN A VALID PLT RESULT COULD NOT BE DETERMINED, THE LABORATORY SENT THE SAMPLE TO A REFERENCE LABORATORY FOR CONFIRMATORY TESTING. THE SAMPLE WAS ANALYZED AND GENERATED A CRITICALLY LOW PLT RESULT. THE RESULT WAS CALLED TO THE PHYSICIAN. THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY DEPARTMENT FOR INPATIENT CARE. THE LABORATORY STATED THE PATIENT EXPERIENCED A DELAY IN TREATMENT/PATIENT CARE DUE TO THE INCONSISTENT PLT RESULTS. THE TYPE OF TREATMENT/PATIENT CARE IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM DUE TO THE DELAY IN TREATMENT/PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760619 XT-4000I AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XT-4000I

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other