BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XS-1000I ANALYZER

    MDR report key: 3487781 · Received November 6, 2013

    Report

    Report Number
    3009711478-2013-00013
    Event Type
    Other
    Date Received
    November 6, 2013
    Date of Event
    October 7, 2013
    Report Date
    October 8, 2013
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K060656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE XS-1000I INSTRUMENT DID WARN THE USER OF AN ABNORMALITY IN THE ANALYSIS REQUIRING VERIFICATION WITH ANY "POSITIVE" JUDGMENTS. PARAMETERS DIFFERING FROM THE INITIAL TESTING WERE NOT LIMITED TO THE HGB OR ANY OF THE RBC PARAMETERS ALONE; THE WBC AND PLATELET VALUES WERE LOWER THAN PREVIOUSLY REPORTED AND WHEN REPEATED, THE VALUES WERE REPRODUCIBLE. THIS LEADS TO A QUESTION AS TO SAMPLE INTEGRITY. THE PT WAS NOT REDRAWN UNTIL THE FOLLOWING MORNING, AFTER THE TRANSFUSION OF THE PACKED RBC. THE USER ULTIMATELY IS RESPONSIBLE FOR PRE-ANALYTIC PROPER COLLECTION AND HANDLING OF PT SAMPLES, AS WELL AS THE VERIFICATION OF RESULTS. NO SMEAR REVIEW WAS PERFORMED. THE ERROR LOGS AROUND THE TIME OF THE OCCURRENCE WERE REVIEWED. NO INDICATION OF MECHANICAL MALFUNCTION WAS LISTED. ANALYZER DATA FROM QUALITY CONTROL AND PEER GROUP QUALITY CONTROL REPORTS SHOWED THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AND HISTORICAL DATA DID NOT REVEAL AN ANALYZER ISSUE. THIS ISSUE IS REPORTED BECAUSE INCORRECT RESULTS LED AN UNNECESSARY TRANSFUSION WITH ASSOCIATED RISKS OF POSSIBLE INCOMPATIBILITY, TRANSFUSION REACTION AND ANTIBODY FORMATION.

    Description of Event or Problem · 1

    THE USER OF AN XS-1000I AUTOMATED HEMATOLOGY ANALYZER (SERIAL NUMBER(B)(4)) ON (B)(6) 2013, REPORTED AN ERRONEOUS LOW HEMOGLOBIN (HGB) RESULT TO A PHYSICIAN RESULT IN A (B)(6)-YR-OLD FEMALE WITH CONGESTIVE HEART FAILURE TO BE TRANSFUSED UNNECESSARILY. THE PT WAS DRAWN ON THE EVENING OF (B)(6) 2013, SAMPLE ID(B)(4). AN HGB VALUE OF 10.1 G/DL WAS OBTAINED. THE PT WAS DRAWN THE FOLLOWING MORNING, AT WHICH TIME THE HGB WAS 7.9. THE ANALYZER JUDGE THE SAMPLE AS "POSITIVE" AND GENERATED AN RBC INTERPRETIVE PROGRAM (IP) MESSAGE FLAG "ANEMIA." THE SAMPLE WAS REPEATED WITH SIMILAR RESULTS. THE PT WAS TESTED AGAIN THE FOLLOWING DAY, SAMPLE ID (B)(4), AT WHICH TIME THE HGB WAS 11.5 G/DL AFTER A TRANSFUSION OF TWO UNITS OF PACKED RED BLOOD CELLS (RBC). THE INCREASE IN THE HGB LEVEL WAS LARGER THAN EXPECTED, SO THE LAB INVESTIGATED. THE DRAWS WERE UNCOMPLICATED. THE PT WAS NOT ON IV FLUIDS DUE TO FLUID INTAKE RESTRICTIONS. SAMPLES WERE COLLECTED FROM THE RIGHT ARM ON (B)(6), AND FROM THE LEFT ARM ON (B)(6). THE PT SUFFERED NO ILL EFFECTS AS A RESULT OF THE TRANSFUSION AND WAS RELEASED WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572790 SYSMEX XS-1000I ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XS-1000I

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other