BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XN-10 ANALYZER

    MDR report key: 3608619 · Received November 22, 2013

    Report

    Report Number
    3009711478-2013-00017
    Event Type
    Other
    Date Received
    November 22, 2013
    Date of Event
    September 17, 2013
    Report Date
    September 17, 2013
    Manufacturer
    SYSMEX CORP
    Product Code
    GKZ
    PMA / PMN Number
    K112605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FAILURE OR MALFUNCTION OF THE ANALYZER WAS REPORTED. THIS ISSUE WAS REPORTED ON THE BASIS THAT THE INCORRECT RESULTS MAY PREVENT NECESSARY TREATMENT SUCH AS BLOOD TRANSFUSION. WHETHER DELTA CHECKS, OR OTHER COMPLETE BLOOD COUNT TEST RESULTS WERE AVAILABLE TO CHECK CONSISTENCY WITH THE PT'S PREVIOUS RESULTS IS UNK, AND THE REASON FOR REPEATING THE SAMPLE 30 MINUTES LATER IS UNK. NO INFO REGARDING INVESTIGATION OF SAMPLE INTEGRITY OR HANDLING (CLOTS, IMPROPER MIXING DURING COLLECTION OR PRIOR TO ANALYSIS, DELAY BETWEEN COLLECTION AND ANALYSIS WHERE THE SAMPLE MAY HAVE SETTLED) WAS PROVIDED, BUT MAY BE A SOURCE OF THE ERRONEOUS RESULTS. NO ANALYZER MESSAGES ALERTED THE USER TO A POSSIBLE SAMPLE ABNORMALITY. THE EVENT WAS INVESTIGATED BY SYSMEX CORP (B)(4). ELEVATED HGB RESULTS MAY POSSIBLY OCCUR IF THE SAMPLE IS ALLOWED TO SETTLE THEN PLACED ON SAMPLER RACK WITH A LACK OF MIXING, OR IF THE SAMPLE TUBE WAS FILLED IN EXCESS OF REQUIRED VOLUME. THIS MAY CAUSE CLOTTING OF THE SAMPLE DUE TO INADEQUATE ANTICOAGULANT CONTACT, IT MAY ALSO CAUSE THE FAILURE TO PROPERLY MIX SAMPLE IF THE TUBE IS OVERFILLED. SYSMEX (B)(4) RELEASED AN URGENT FIELD SAFETY NOTICE THAT DESCRIBED THE POTENTIAL RISK TO PT HEALTH THAT COULD BE CAUSED BY THE POSSIBLE REPORTING OF FALSELY HIGH HEMOGLOBIN VALUES ON THE XN-SERIES ANALYZERS.

    Description of Event or Problem · 1

    THE USER OF AN XN-10 AUTOMATED HEMATOLOGY ANALYZER IN A XN-9000 CONFIGURATION LOCATED IN (B)(6) REPORTED TO SYSMEX (B)(4), LIMITED THAT A INCORRECT, ELEVATED HEMOGLOBIN (HGB) RESULT OF 151 G/L WAS GENERATED AND REPORTED, BUT THE HGB WAS 82 G/L ON REPEAT ANALYSIS. THE SAMPLE ID (B)(6) WITH HGB=151 G/L DID NOT GENERATE AN INTERPRETIVE PROGRAM (IP) MESSAGE OR ERROR, AND THE RESULT WAS REPORTED. THE REPEAT ANALYSIS OF THE SAMPLE APPROX 30 MINUTES LATER, HGB=82 G/L. THE REPORTER STATED THE PREVIOUS HGB RESULTS FOR THIS PT, DATE OF ANALYSIS UNK, WAS HGB = 85 G/L. NO SERIOUS DETERIORATION OF HEALTH WAS REPORTED. NO SAMPLE PRINTOUTS OR SCREENSHOTS WERE PROVIDED. THE REPORT STATED THAT DEPENDING UPON OTHER SIGNS AND SYMPTOMS, THE PHYSICIAN MAY HAVE WANTED TO ORDER A TRANSFUSION FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610139 SYSMEX XN-10 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORP XN-10

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other