BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XE-2100 AUTOMATED HEMATOLOGY ANALYZER

    MDR report key: 2653468 · Received February 24, 2010

    Report

    Report Number
    1422681-2010-00001
    Event Type
    Other
    Date Received
    February 24, 2010
    Date of Event
    January 25, 2010
    Report Date
    February 24, 2010
    Manufacturer
    SYSMEX CORP.
    Product Code
    GKZ
    PMA / PMN Number
    K992875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS ANALYZED BY THE MFR. THE FIELD SERVICE REP (FSR) WAS DISPATCHED TO EVALUATE THE INSTRUMENT IN RESPONSE TO THE REPORTED EVENT. THE FSR EVAL DETERMINED THAT THE ANALYZER WAS PERFORMING WITHIN SPECS AND NO ADJUSTMENT TO CALIBRATION OR OTHER SETTINGS WAS NEEDED. IN ADDITION, THE USER'S INSIGHT (QC PEER GROUP REPORTS) WERE REVIEWED BY THE COMPLAINT INVESTIGATOR, THE REVIEW INDICATED THAT THE ANALYZER IS PERFORMING WITHIN +/- 2.0 SDI OF THE PEER GROUP. EVAL OF THE PT RESULT PRINTOUT FOR THE ER SAMPLE # (B)(4) INDICATED THAT THE REPORT WAS FLAGGED "POSITIVE", PER THE XE-2100 OPERATOR'S MANUAL, POSITIVE SAMPLES REQUIRE FURTHER EVAL BY THE LABORATORY PRIOR TO REPORTING RESULTS, THE COMPLAINT INVESTIGATOR DETERMINED WITH THE USER THAT A SLIDE HAD BEEN MADE FOR THE SAMPLE, BUT HAD NOT BEEN REVIEWED PRIOR TO REPORTING THE RESULTS TO THE ER. IN ADDITION, THE REPORT HAD AN IP MESSAGE FLAG FOR "NEUTROPHILIA" WHICH ALSO INDICATES FURTHER REVIEW IS REQUIRED. THE LIKELY ROOT CAUSE FOR THE ERRONEOUS RESULT WAS DUE TO SAMPLE INTEGRITY, THE INITIAL ER SAMPLE WAS UNACCEPTABLE PER GOOD LABORATORY PRACTICE, BASED ON THE FACT THAT A LARGE CLOT WAS FOUND NEAR THE TOP OF THE TUBE; THIS SAMPLE IS UNACCEPTABLE FOR ANALYSIS. THERE WAS NO INDICATION, BASED ON FSR EVAL OF THE ANALYZER, AND INVESTIGATOR REVIEW OF QC REPORTS THAT THE ANALYZER MALFUNCTIONED AND CAUSED OR CONTRIBUTED TO THIS EVENT. METHOD EVAL: EVAL OF PT DATA PROVIDED BY HOSP AND QC PEER GROUP DATA.

    Description of Event or Problem · 1

    THE USER OF AN XE-2100 AUTOMATED HEMATOLOGY ANALYZER (SERIAL NUMBER (B)(4)) REPORTED TO SYSMEX AMERICA, INC ON (B)(4) 2010, THAT A PT HAD BEEN TRANSFUSED BASED ON AN ERRONEOUS HEMOGLOBIN RESULT. THE PT WAS IN THE EMERGENCY ROOM, AND THE FOLLOWING RESULTS WERE REPORTED ((B)(6) 2010 AT 2239): HEMOGLOBIN: 8.5 G/DL. HEMATOCRIT: 25.5%. PLATELET: 88 10^3/UL. THE USER REPORTED THESE RESULTS. THE EMERGENCY ROOM (ER) PHYSICIAN HAD DIAGNOSED THIS PT AS HAVING AN ABDOMINAL BLEED, AND THE PT WAS GIVEN 2 UNITS OF FRESH FROZEN PLASMA (FFP) AND LEUKOREDUCED RBC'S. A POST-TRANSFUSION SAMPLE WAS DRAWN AND RUN, AND THE RESULTS WERE DELTA CHECKED. THE USER THEN CHECKED THE ORIGINAL SAMPLE AND FOUND THAT THERE WAS A LARGE CLOT CONTAINED AT THE TOP OF THE TUBE. THE USER REPORTED TO SYSMEX THAT THERE HAD BEEN NO KNOWN ADVERSE EFFECT TO THE PT AS A RESULT OF THE TREATMENT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX XE-2100 AUTOMATED HEMATOLOGY ANALYZER XE-2100 GKZ SYSMEX CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other