BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS)

    MDR report key: 3432835 · Received October 16, 2013

    Report

    Report Number
    3009711478-2013-00012
    Event Type
    Other
    Date Received
    October 16, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SYSMEX AMERICA INC.
    Product Code
    GKZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SCREEN SHOTS COLLECTED FROM THE WAM DEMONSTRATED THAT A SAMPLE ID (B)(6), CAME FROM A (B)(6) MALE. THE COMPLAINANT TEXT STATES THAT THE ERRONEOUS RESULTS WERE BROUGHT TO THE USER'S ATTENTION BY A NURSE AT (B)(6). THE RISK MANAGER WAS CONTACTED TO CLARIFY. SHE STATED THAT THE RESULTS IN QUESTION WERE REGARDING AN ADOLESCENT, NOT A (B)(6) MALE. SHE WAS CONTACTED FOR FURTHER CLARIFICATION, BUT COULD NOT BE REACHED FOR THE ADDITIONAL INFO. THE WAM VALIDATION SCREEN CONTAINED TWO OPERATOR ALERTS, "RETIC LINEARITY EXCEEDED" AND "CONFIRM NRBC." THESE INFORM THE OPERATOR THAT VERIFICATION IS NECESSARY PRIOR TO REPORTING. REPEAT TESTING AND/OR PERIPHERAL SMEAR REVIEW WERE INDICATED, BUT IT IS NOT KNOW IF THOSE STEPS WERE TAKEN. THE RULE WAS AUDITED AND MODIFICATIONS WERE MADE DURING A (B)(4) TIME FRAME FROM (B)(4) 2012. A MODIFICATION TO THE LOWER LIMIT CAUSED RESULTS TO BE REPORTED INCORRECTLY. CORRECT RESULTS WERE GENERATED BY THE ANALYZER. THE WAM IS USED IN CONJUNCTION WITH AUTOMATED ANALYZERS AS PART OF A SCREENING PROTOCOL TO IDENTIFY ABNORMALITIES IN PT SAMPLES. THE USER IS RESPONSIBLE FOR SETTINGS ON THE INSTRUMENTATION AND THE WAM SUCH THAT ABNORMALITIES ARE IDENTIFIED. WHENEVER A RULE IS ENTERED OR MODIFIED, THE USER MUST TEST THE RULE TO ENSURE THAT IT WORKS AS INTENDED. (B)(4) REQUIRES THAT THE USER VERIFY BY TESTING THE MFR'S PERFORMANCE SPECS FOR ACCURACY, PRECISION, REPORTABLE RANGE AND REFERENCE INTERVALS BEFORE REPORTING PT RESULTS. THE USER MUST ALSO VERIFY FUNCTIONALITY OF THE SYSTEM, INCLUDING APPROPRIATE UNITS OF MEASURE, FLAGS, ALERTS, INTERPRETIVE COMMENTS, ETC AFTER MODIFICATIONS ARE MADE.

    Description of Event or Problem · 1

    THE USER OF THE WORK AREA MANAGEMENT (WAM) SYSTEM MIDDLEWARE, VERSION 4.1, SERIAL NUMBER (B)(4), REPORTED TO THE TECHNICAL ASSISTANCE CENTER (TAC) ON (B)(6) 2012 AN OCCURRENCE IN WHICH A RULE, RULE RBC014.2, IN THE WAM WAS WRITTEN INCORRECTLY CAUSING ELEVATED RETICULOCYTE (RETIC) COUNTS TO BE REPORTED AS LESS THAN 0.45 PERCENT. THE RULE WAS WRITTEN CORRECTLY IN THE TEST ENVIRONMENT, BUT NOT IN THE PRODUCTION ENVIRONMENT. CONFLICTING INFO WAS PROVIDED BY THE LAB USER AND THE RISK MANAGEMENT AREA. THE ISSUE, AS ORIGINALLY REPORTED, STATED THAT A LOW, ERRONEOUS RETIC COUNT WAS REPORTED ON A (B)(6) PT, CAUSING THE PT TO RECEIVE TWO UNITS OF PACKED RBC. HIS RETIC COUNT WAS ACTUALLY 2.81 INSTEAD OF <0.45. THE RISK MANAGER STATED THAT SHE DID NOT KNOW OF A CIRCUMSTANCE IN WHICH A PT WAS TRANSFUSED UNNECESSARILY. SHE DID KNOW OF TWO INCORRECT RESULTS REPORTED ON A (B)(6) AND A (B)(6) BEING TREATED AT (B)(6). SUBSEQUENT ATTEMPTS TO CONTACT THE RISK MANAGER DID NOT YIELD ANY ADDITIONAL INFO REGARDING ANY IMPACT TO THE CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530072 SYSMEX WORK AREA MANAGEMENT SYSTEM (MDDS) MIDDLEWARE GKZ SYSMEX AMERICA INC. WAM V. 4.1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other