BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XE-5000 ANALYZER

    MDR report key: 2167123 · Received June 14, 2011

    Report

    Report Number
    1422681-2011-00002
    Event Type
    Other
    Date Received
    June 14, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 16, 2011
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K071967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYSMEX FIELD SERVICE REPRESENTATIVE (FSR) WENT ON-SITE TO VERIFY PROPER FUNCTIONING OF THE ANALYZER INCLUDING PERFORMING QUALITY CONTROL. DATA FROM SAMPLES RUN BEFORE AND AFTER THE SPECIMEN IN QUESTION, AS WELL AS THE ERROR LOG, AUDIT LOG, IPU AND CONTROLLER SETTINGS WERE REVIEWED BY A TECHNICAL SUPPORT MANAGER FOR THE XE-5000 ANALYZER. A DEFINITIVE ROOT CAUSE FOR THE SPURIOUS LOW HEMOGLOBIN VALUE COULD NOT BE DETERMINED. IMPROPER FLOW CELL DRAINING WAS RULED OUT BECAUSE THE BLANK READING WAS WITHIN SPECIFICATIONS. NONE OF THE SAMPLES BEFORE AND AFTER THIS ONE DISPLAYED AN ERROR OR ERRONEOUS READING. INSIGHT QUALITY CONTROL (QC) DATA FOR ALL THREE LEVELS WERE REVIEWED FOR THE DATE IN QUESTION AS WELL AS THE DAY BEFORE AND AFTER; ALL CONTROL PARAMETERS WERE WITHIN PACKAGE INSERT RANGES. THE ANALYZER WAS FOUND TO BE PERFORMING PER SPECIFICATIONS. THE SYSMEX XE-5000 ANALYZER WAS PERFORMING AS EXPECTED; NO MALFUNCTION WAS IDENTIFIED. THE LACK OF USER-DEFINED INTERPRETIVE MESSAGES WAS THE CAUSE OF LOW HEMOGLOBIN RESULTS BEING JUDGED "NEGATIVE," AND THE USER REPORTED THE RESULTS TO THE CLINICIAN. THE INSTRUMENT IDENTIFIED THE RESULTS AS OUTSIDE OF THE MARK LIMITS. THERE WAS NO REPORTED ADVERSE EVENT TO THE PT AS A RESULT OF THE BLOOD TRANSFUSION RECEIVED. SYSMEX IS REPORTING THIS EVENT TO THE FDA DUE TO THE INHERENT RISK TO A PT AS A RESULT OF A TRANSFUSION. SOME OF THE POTENTIAL ADVERSE OUTCOMES ARE NOT IMMEDIATELY EVIDENT. THE USER-DEFINED SETTINGS WERE SET AS REQUESTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE USER REPORTED THAT A (B)(6) WOMAN WAS TRANSFUSED WITH TWO UNITS OF PACKED RBC. THE PT WAS ADMITTED TO THE EMERGENCY ROOM (ER) FOR AN UNSPECIFIED REASON. A BLOOD SAMPLE WAS COLLECTED AND ANALYZED ON THE SYSMEX XE-5000 ANALYZER, SERIAL NUMBER (B)(4), IN THE AUTOMATED MODE (B)(6) 2011 AT 14:03:05, WITHIN ONE HOUR OF COLLECTION. THE SAMPLE WAS JUDGED "NEGATIVE" BECAUSE NO INTERPRETIVE MESSAGES WERE TRIGGERED. THERE WERE MULTIPLE "-" SIGNS NEXT TO THE HGB (7.0), MCH (17.9), AND MCHC (17.9) PARAMETERS. THE +/- SIGNS INDICATE THE DATA WAS OUTSIDE OPERATOR DEFINED "MARK LIMITS" USED TO INDICATE REFERENCE RANGES. THE USER'S LOWER LIMIT ON HEMOGLOBIN VALUE IS SET FOR LESS THAN 7.0 MG/DL TO TRIGGER AN "ANEMIA" MESSAGE. THE USER DID NOT DEFINE LIMITS TO USE THE "HYPOCHROMIA" FLAG, THE LIS IS NOT SET FOR AUTO-VERIFICATION, SO THE RESULTS MUST BE REVIEWED PRIOR TO RELEASE. THE USER SAW THE "NEGATIVE" INTERPRETATION AND RELEASED THE RESULTS WITHOUT FURTHER REVIEW OR REPEAT. THE ERRONEOUS RESULTS WERE DETECTED AFTER THE PT WAS TRANSFUSED. THE HEMOGLOBIN WAS 16.0 POST-TRANSFUSION. ONE UNIT OF PACKED RBC GENERALLY RESULTS IN APPROX A 1 G/DL RISE IN HEMOGLOBIN. PHYSIOLOGICALLY, IT IS NOT LIKELY TO SEE SUCH A RISE. MULTIPLE ATTEMPTS (ON (B)(6) 2011) WERE MADE TO OBTAIN ADDITIONAL INFO. THE FACILITY DECLINED TO PROVIDE REASON FOR ADMISSION, DIAGNOSIS, OR DESCRIPTION OF ADDITIONAL SYMPTOMS THAT LEAD TO THE DECISION TO TRANSFUSE. REPRESENTATIVES FROM RISK MANAGEMENT AND THE LABORATORY WERE REACHED ON (B)(6) 2011, STATING THAT THE SYMPTOMS WERE CONSISTENT WITH THE NEED TO TRANSFUSE. IT WAS REPORTED THAT NO TRANSFUSION REACTION OCCURRED NOR HAVE THERE BEEN ANY OTHER ADVERSE EFFECTS ON THE PT. THE PT WAS SUBSEQUENTLY DISCHARGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other