BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XE-5000 ANALYZER

    MDR report key: 2549035 · Received April 20, 2012

    Report

    Report Number
    1422681-2012-00006
    Event Type
    Other
    Date Received
    April 20, 2012
    Date of Event
    September 27, 2011
    Report Date
    April 20, 2012
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K071967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE FOR A SPURIOUS LOW HEMOGLOBIN VALUE COULD NOT BE DETERMINED. HEMOGLOBIN WAS NOT THE ONLY LOW VALUE; THE RBC AND HEMATOCRIT WERE LOW AS WELL. THESE PARAMETERS ARE ANALYZED IN SEPARATE CHANNELS. ADD'L INFO IS NOT AVAILABLE. INSIGHT QUALITY CONTROL (QC) DATA FOR ALL THREE LEVELS WERE REVIEWED FOR THIS TIME PERIOD; ALL CONTROL PARAMETERS WERE WITHIN PACKAGE INSERT RANGES. HISTORICAL DATA DID NOT REVEAL ANY ANALYZER ISSUES. A SAMPLE-RELATED ABNORMALITY COULD NOT BE RULED OUT. THE COLLECTION METHOD OF THE SAMPLE IS NOT KNOWN. SAMPLES FROM NEWBORNS TYPICALLY ARE COLLECTED BY CAPILLARY HEEL-STICK. THESE SAMPLES HAVE THE POTENTIAL TO CLOT EASILY WHEN EXPOSED TO TISSUE FLUIDS AND WHEN DELAYS ARE INCURRED BEFORE EXPOSURE TO ANTICOAGULANT. THE USER STATES THAT NO TRANSFUSION REACTION OCCURRED, NOR HAVE THERE BEEN ANY OTHER ADVERSE EFFECTS ON THE PT. THE USER REPORTS THAT THE CHILD IS HEALTHY AND DOING FINE CURRENTLY. NO PT IMPACT OCCURRED BECAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    THE USER ATTEMPTED TO GATHER INFO FROM TESTING PERFORMED ON SEPTEMBER 27, 2011 THROUGH THE WORK AREA MANAGEMENT (WAM) MIDDLE-WARE AND CONTACTED SYSMEX ON MAR 21, 2012 FOR ASSISTANCE. THE USER HAS TWO XE-5000 ANALYZERS, BUT IT IS NOT KNOWN ON WHICH ANALYZER THE TESTING WAS PERFORMED. THE ANALYZER GENERATED A HEMOGLOBIN (HGB) OF 5.4 G/DL, LEADING TO THE TRANSFUSION OF A NEWBORN BOY WITH PACKED RBC. A POST-TRANSFUSION ANALYSIS THE FOLLOWING DAY YIELDED AN HGB OF 12.4. NO ORIGINAL INFO FROM THE ANALYZER OR WAM IS AVAILABLE BECAUSE DATA OLDER THAN A USER-DEFINED TIME PERIOD IS PURGED PERIODICALLY. THE ANALYZER JUDGES EACH SAMPLE AS TO THE PRESENCE OR LACK OF ABNORMALITY INDICATING POSITIVE OR NEGATIVE ACCORDING TO USER-DEFINED LIMITS. THE USER'S LOWER LIMIT ON HEMOGLOBIN VALUE IS SET FOR LESS THAN 9.0 G/DL, SO IT IS LIKELY THAT AN "ANEMIA" MESSAGE WAS TRIGGERED WITH A VALUE OF 5.4. NEWBORNS REQUIRING TRANSFUSION ARE GIVEN A PORTION OF A UNIT OF PACKED RBC (FOR EXAMPLE 60 ML) DEPENDENT UPON BIRTH WEIGHT, SUFFICIENT TO CAUSE A 1 G/DL RISE IN HEMOGLOBIN. PHYSIOLOGICALLY, A RISE OF 7 G/DL AFTER TRANSFUSION IS NOT LIKELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other