BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XN-10 ANALYZER

    MDR report key: 3515020 · Received December 3, 2013

    Report

    Report Number
    3009711478-2013-00016
    Event Type
    Other
    Date Received
    December 3, 2013
    Date of Event
    November 6, 2013
    Report Date
    November 6, 2013
    Manufacturer
    SYSMEX CORPORATION,
    Product Code
    GKZ
    PMA / PMN Number
    K112605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DATA PROVIDED DISPLAYS INITIAL ANALYSIS OF THE SAMPLE ID HAD AN ABNORMAL PLT HISTOGRAM. THIS ALERTS THE OPERATOR TO VERIFY RESULTS PRIOR TO REPORTING. THE USER DOES NOT HAVE ABNORMAL PLATELET SETTINGS ACTIVE. THE PURPOSE OF THESE SETTINGS, KNOWN AS IP MESSAGE FLAGS, IS TO NOTIFY THE OPERATOR OF THE POSSIBILITY OF A SAMPLE ABNORMALITY BASED ON THE EXAMINATION OF THE ANALYSIS DATA. THE USER CHOSE NOT TO EMPLOY THE ABNORMAL LOW "THROMBOCYTOPENIA" PLT FLAG. THE DEFAULT SETTING FOR THIS FLAG IS PLT <60 X 10 TO THE POWER OF 3/UL. THE PLT-F CHANNEL IS USED TO MEASURE PLATELETS WITH ACCURACY, PRIMARILY LOW PLT COUNTS. THE "PLT CLUMPS?" FLAG. IF ANY OF THE FOLLOWING ARE PRESENT, THE SYSTEM MAY ERRONEOUSLY REPORT A LOW PLT COUNT: PLT CLUMPS, PSEUDOTHROMBOCYTOPENIA (CAUSED BY EDTA TYPICALLY), GIANT PLTS. AN ASTERISK, "*," WAS ATTACHED TO ONE OF THE COUNTS, INDICATING THAT AN INTERFERENCE IS PRESENT. PLT CLUMPING CAN BE CAUSED BY THE PRESENCE OF ABNORMAL PROTEINS THAT ENCOURAGE PLT CLUMPING WHEN THE SAMPLE IS EXPOSED TO EDTA ANTICOAGULANT. THE USER CAN NEGATE THIS EFFECT BY COLLECTING A SAMPLE IN SODIUM (NA) CITRATE ANTICOAGULANT AND PERFORMING PLATELET ANALYSIS. FIELD SERVICE (FSR) WAS DISPATCHED TO INSPECT THE ANALYZER; NO ANALYZER MALFUNCTION WAS IDENTIFIED. GOOD LABORATORY PRACTICE REQUIRES THE USER TO VERIFY ANY VALUES THAT ARE QUESTIONABLE OR ARE CONSIDERED CRITICAL AS IN THIS EVENT. THE ANALYZER PERFORMED WITHIN MANUFACTURER'S SPECIFICATION. THIS EVENT IS REPORTED ON THE BASIS THAT INCORRECT RESULTS MAY HAVE LED TO THE PATIENT RECEIVING A SURGICAL PROCEDURE CARRYING WITH IT THE RISKS INVOLVED WITH RECEIVING SURGERY.

    Description of Event or Problem · 1

    THE USER OF AN XN-10 ANALYZER, IN AN XN-9000 CONFIGURATION REPORTED AN ERRONEOUS LOW PLATELET (PLT) RESULT THAT WAS REPORTED AND POSSIBLY CAUSED A PATIENT ON STROKE ALERT TO RECEIVE AN UNNECESSARY SURGICAL PROCEDURE. THE PATIENT WAS SEEN AT AN UNKNOWN FACILITY FIRST AND WAS REFERRED TO THE EMERGENCY ROOM (ER) OF THE UNIV OF KY MEDICAL CENTER. (B)(6). THE ANALYZER, SERIAL NUMBER (B)(4), GENERATED A PLT VALUE OF 43 X 10 TO THE POWER OF 3 UL. THE ANALYZER JUDGED THE SAMPLE AS "NEGATIVE," WITH NO INTERPRETIVE PROGRAM (IP) MESSAGES. THE SAMPLE WAS NOT REPEATED PRIOR TO REPORTING. THE TECHNOLOGIST PREPARED A PERIPHERAL SMEAR; HOWEVER, IT WAS NOT REVIEWED PRIOR TO REPORTING. THE COMPLAINANT REPORTED THE EMERGENCY ROOM DOCTOR CHANGED THE PATIENT'S METHOD OF TREATMENT BASED ON THE PLT COUNT. THE PATIENT WAS SENT TO SURGERY AS OPPOSED TO BEING GIVEN TISSUE PLASMINOGEN ACTIVATOR (TPA). WHILE THE PATIENT WAS IN RECOVERY, THE EMERGENCY ROOM DOCTOR ORDERED ANOTHER TEST. THE SAMPLE WAS REPEATED 4 HOURS LATER ON THE ANALYZER 11830. THIS TIME THE PLT VALUE WAS 174 X 10 TO THE POWER OF 3 UL WAS JUDGED "POSITIVE" WITH IP MESSAGE "PLT CLUMPS?" PLT CLUMPS WERE OBSERVED UPON SMEAR REVIEW. A CORRECTED REPORT WAS ISSUED. THE PATIENT RECOVERED WELL FROM SURGERY AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626058 SYSMEX XN-10 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION, XN-10

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other