BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XT-2000I

    MDR report key: 2136553 · Received February 5, 2008

    Report

    Report Number
    1422681-2008-00002
    Event Type
    Other
    Date Received
    February 5, 2008
    Date of Event
    January 6, 2008
    Report Date
    February 1, 2008
    Manufacturer
    SYSMEX CORP
    Product Code
    GKZ
    PMA / PMN Number
    K021241
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT WAS REPORTED TO SYSMEX AS INTERMITTENT LOW HGB AND MCHC VALUES. REVIEW OF PT SAMPLE DATA ANALYZED BETWEEN 05:33 AND 07:27 (B)(6) 2008, SHOWED A PATTERN OF SPECIMENS WITH LOW HGB AND MCHC VALUES, NO OTHER PARAMETERS WERE SUSPECTED. THE OPERATOR RETROSPECTIVELY REPEATED 17 SUSPECT SAMPLES AFTER THE TRANSFUSION EVENT. THE FACILITY REPORTED ASPIRATING A CLOTTED SPECIMEN ON THE DAY OF THE EVENT (B)(6) 2008, AND ANALYZER MAINTENANCE AND CLEANING WAS PERFORMED. THE QC AND HGB RESULTS WERE SAID TO BE OK. THE LAB INFO SYSTEM (LIS) "DECRYPTIC" ALERT WAS SET FOR HGB LESS THAN 65 G/L, BUT NO ALERT WAS USED FOR LOW MCHC VALUES. LIS DELTA CHECK FOR HGB WAS SET TO DETECT 30 G/L HGB DECREASE. AS OF (B)(6) 2008, AN ALERT WAS SET FOR MCHC LESS THAN 295 G/L. ANALYZER QC IS VERIFIED ONLY ONCE PER 24 HOURS. LACK OF RECOGNITION OF A PATTERN OF INACCURATE RESULTS AND MINIMAL USE OF USER DEFINED DETECTION SETTINGS BOTH ON THEIR SYSMEX ANALYZER AND THEIR DECRYPTIC LAB INFO SYSTEM APPEAR TO HAVE CONTRIBUTED TO THIS INCIDENT. LIS ALERTS AND ANALYZER FLAGS HELP PREVENT REPORTING OF INVALID RESULTS AND ARE CONSIDERED AN IMPORTANT PART OF GOOD LABORATORY PRACTICE. SYSMEX SERVICE PERSONNEL EVALUATED THE DEVICE AND COULD NOT PRODUCE LOW HGB VALUES. SERVICE ON THE HGB AND SAMPLE ASPIRATION MODULE WAS PERFORMED. THE PERFORMANCE OF ANALYZER WAS VERIFIED WITH PRECISION AND CALIBRATION. QC DATA AND ERROR MESSAGES THAT MAY HAVE OCCURRED AT THE TIME OF THE INCIDENT WERE NOT AVAILABLE. THE CAUSE OF THE LOW HGB VALUES COULD NOT BE DETERMINED. ADDITIONALLY, REVIEW OF THE SULFOLYSER HEMOGLOBIN REAGENT DEVICE HISTORY RECORD FOR THE LOT ON THE ANALYZER DURING THE INCIDENT DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    A SYSMEX XT-2000I ANALYZER USED OUTSIDE THE UNITED STATES, (B)(6) REPORTED A HEMOGLOBIN (HGB) VALUE THAT WAS 80 G/L AND MCHC=256 G/L. THE PT WAS TRANSFUSED WITH 2 UNITS OF BLOOD ON 1/6/2008. THE PT WAS BLEEDING, AND HIS DIAGNOSIS WAS PNEUMONIA, SEPSIS AND MI. NO ADVERSE EFFECT TO THE PT WAS REPORTED DUE TO THE TRANSFUSION. THE RESULT WAS FLAGGED BY THE ANALYZER AS "POSITIVE", INDICATING THE SPECIMEN RESULTS REQUIRED REVIEW. THE USER-DEFINED ANALYZER FLAG TO DETECT LOW MCHC WAS NOT USED, AND THE FLAG FOR LOW HGB VALUES WAS SET TO DETECT VALUES BELOW 40 G/L. THE RBC AND HEMATOCRIT (HCT) VALUES DID NOT AGREE WITH THE HGB VALUES OBTAINED ON THE ORIGINAL ANALYSIS OF THE SPECIMEN. THE LAB BECAME SUSPICIOUS OF SPECIMENS WITH LOW MCHC'S, AND REPEATED THE ORIGINAL SPECIMEN ON THE SAME ANALYZER 10 HOURS LATER: HGB=97 G/L, AND MCHC=284 G/L WITH POSITIVE FLAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX XT-2000I AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORP XT-2000I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other NOT PROVIDED