BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XE-5000

    MDR report key: 2867748 · Received December 6, 2012

    Report

    Report Number
    1422681-2012-00013
    Event Type
    Other
    Date Received
    December 6, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K071967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE WAS DISPATCHED TO EXAMINE THE ANALYZER. DATA FROM THE INCIDENT AND QUALITY CONTROL DATA WAS REVIEWED BY SYSMEX TECHNICAL SUPPORT MANAGERS TO VERIFY PROPER FUNCTION OF THE ANALYZER. NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE SPECIMEN IN QUESTION WAS NOT REPEATED, NOR A BLOOD SMEAR REVIEWED BY THE USER TO VERIFY THE RESULTS. THE ERROR LOG WAS PROVIDED; NO FUNCTIONAL ERROR WAS TRIGGERED ON THE SAMPLE (SHORT SAMPLE, ASPIRATION ERRORS, ETC.) ANALYZER DATA FROM QUALITY CONTROL AND PEER GROUP INSIGHT QUALITY CONTROL REPORTS SHOWED THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AND HISTORICAL DATA DID NOT REVEAL AN ANALYZER ISSUE. POTENTIAL SAMPLE-SPECIFIC ABNORMALITIES SUCH AS MICRO-CLOTS, FIBRIN OR BUBBLES IN THE SAMPLE IN QUESTION, COULD NOT BE RULED OUT. BECAUSE ALL PARAMETERS WERE DIFFERENT UPON REPEAT TESTING, A POTENTIAL CAUSE WAS INCOMPLETE SAMPLE MIXING THAT AFFECTED THE ENTIRE SAMPLE, NOT JUST THE HEMOGLOBIN. THE SAMPLE WAS RECEIVED IN THE LABORATORY AT 10:01, IT WAS NOT ANALYZED UNTIL 11:42. STORAGE CONDITIONS WERE NOT NOTED. THE SAMPLE MAY HAVE SETTLED AND WAS NOT COMPLETELY RESUSPENDED BEFORE ASPIRATION. IT IS NOT KNOWN WHY THE OPERATOR RELEASED RESULTS WITHOUT REPEAT TESTING AND SMEAR EXAMINATION.

    Description of Event or Problem · 1

    THE LAB MANAGER REPORTED THAT AN XE-5000 (SERIAL NUMBER (B)(4)) AUTOMATED HEMATOLOGY ANALYZER GENERATED AN INCORRECT LOW HEMOGLOBIN (HGB) RESULT OF 7.7 G/DL FOR A CRITICAL PATIENT WHO HAD SUFFERED A GUNSHOT WOUND. THE PATIENT HAD PREVIOUS LEVELS OF BETWEEN 11.5 TO 15.4, BUT WAS PRONE TO SPONTANEOUS BLEEDS. THE SAMPLE ID (B)(6) WAS RUN FOR A COMPLETE BLOOD COUNT (CBC) AND NRBC IN THE AUTOMATED MODE AND WAS JUDGED AS "POSITIVE" WITH A COUNT ERROR AND THE "ANEMIA" INTERPRETIVE MESSAGES BASED ON USER-DEFINED SETTINGS OF HGB <8 G/DL FOR "ANEMIA." THE ANALYZER WAS USED WITH THE SYSMEX WORK AREA MANAGEMENT WAM) MIDDLEWARE, V. 4.01, AND THE OPERATOR ALERTS STATED THE FOLLOWING: "PLT DELTA FAILURE. CHECK TUBE AND SMEAR FOR CLOTS" AND "HGB DELTA FAILURE. CHECK TUBE AND SMEAR FOR CLOTS IF INITIAL SAMPLE." THE RESULTS WERE RELEASED TO THE PHYSICIAN, WHO ORDERED A TRANSFUSION AND AN ANGIOGRAM. A CBC ANALYZED THE FOLLOWING DAY AFTER TRANSFUSION SHOWED THE HGB=11.2 G/DL. THIS WAS APPROXIMATELY A FOUR-GRAM DIFFERENCE FROM THE PREVIOUS DAY. THE NUMBER OF UNITS TRANSFUSED WAS NOT PROVIDED, BUT TYPICALLY ONE UNIT RAISES THE HGB BY ONE GRAM. PREVIOUS RESULTS FROM THIS PATIENT: (B)(6) 2012 23:17: WBC=8.2, RBC=3.77, HGB= 11.5, HCT=34.6, MCV=91.8, MCH=30.5, MCHC=33.2, PLT=114; (B)(6) 2012 00:29 WBC=7.2, RBC=4.95, HGB= 15.4, HCT=45.6, MCV=92.1, MCH=31.1, MCHC=33.8, PLT=196; (B)(6) 2012 21:00 WBC=6.5, RBC=4.90, HGB =15.0, HCT=45.1, MCV=94.0, MCH=31.3, MCHC=33.3, PLT=215; (B)(6) 2012 17:39 HGB= 13.1, HCT=38.3, MCV=92.1, MCHC=34.2, PLT=158; (B)(6) 2012 16:55 WBC=7.5, RBC=4.81, HGB= 15.1, HCT=45.2, MCV=94.0, MCH=31.3, MCHC=33.4, PLT=207.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX XE-5000 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XE-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other