BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3846712 · Received June 4, 2014

    Report

    Report Number
    1061932-2014-01184
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT AND FOUND THE WASTE DRAIN TUBING FROM THE WHITE BLOOD CELL BATH TO BE CRIMPED. THE FSE REPLACED THE TUBING TO ENSURE PROPER ROUTING AND NOTED PROPER FLUID FLOW. THE FSE ALSO PERFORMED START-UP, REPRODUCIBILITY, AND CONTROLS WITH RESULTS IN RANGE AND WITH NO NOTED ERRORS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS COMPLETE BLOOD COUNT (CBC) RESULTS WERE GENERATED ON THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER FOR THREE PATIENTS. THIS REPORT REFERS TO ONE PATIENT WHOSE TREATMENT WAS AFFECTED. THE PATIENT'S SAMPLE WAS RUN ON THE INSTRUMENT AND PRODUCED AN IMMATURE GRANULOCYTE SUSPECT MESSAGE. THIS MESSAGE PROMPTED A SLIDE REVIEW AND THE SAMPLE WAS RERUN PER LABORATORY PROTOCOL ON THE SAME INSTRUMENT. UPON RERUN, THE INSTRUMENT GENERATED FALSE LOW WHITE BLOOD CELL (WBC) COUNT AND HEMOGLOBIN (HGB) RESULTS. THE ERRONEOUS RESULTS WERE REPORTED FROM THE LABORATORY. THE (B)(6) AT THE SITE REPORTED THAT THE PATIENT RECEIVED A BLOOD TRANSFUSION BASED ON THE RESULTS; THE (B)(6) ALSO REPORTED THAT THERE WAS NO MEDICAL INJURY ASSOCIATED WITH THE TRANSFUSION AND THE PATIENT WILL BE NOTIFIED. UPON DISCOVERY OF ERRONEOUS RESULTS, ALL SAMPLES BACK TO THE LAST GOOD QUALITY CONTROL (QC) RESULT THAT DAY WERE SENT TO AN ALTERNATE LABORATORY FOR VERIFICATION OF RESULTS; THE PATIENT SAMPLES WERE TESTED ON AN UNKNOWN INSTRUMENT AND THE RESULTS OBTAINED ARE CONSIDERED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327531 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other