BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3771913 · Received April 25, 2014

    Report

    Report Number
    1061932-2014-00929
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND DISCOVERED BUBBLES IN THE RED BLOOD CELL (RBC) DISPENSER. THE FSE PROCEEDED TO REPLACE THE RBC DILUENT DISPENSER PUMP (PM2) TO RESOLVE THE ISSUE. THE FSE VERIFIED THE REPAIR AS PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. IN CONCLUSION, FAILURE MODE OF THE EVENT IS ATTRIBUTED TO THE RBC DILUENT DISPENSER PUMP; THE INSTRUMENT ALSO GENERATED HEMOGLOBIN AND HEMATOCRIT (H & H) CHECK FAIL FLAGS TO ALERT THE CUSTOMER OF AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RED BLOOD CELL (RBC) DISPENSER OF THE COULTER® LH 780 HEMATOLOGY ANALYZER GENERATED FOAM AND BUBBLES. THE CUSTOMER STATED THAT THE INSTRUMENT ALSO GENERATED HIGH RBC BACKGROUND AND WAS UNABLE TO PASS STARTUP. RBC RESULTS FOR PATIENT SAMPLES WERE ALSO SLIGHTLY AFFECTED BUT THE DIFFERENCE IN RBC RESULTS WAS NOT CLINICALLY SIGNIFICANT AND NOT CONSIDERED TO BE ERRONEOUS. IN ADDITION, THE INSTRUMENT GENERATED HEMOGLOBIN & HEMATOCRIT (H&H) CHECK FLAGS TO ALERT THE OPERATOR OF AN INSTRUMENT ISSUE. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED FOR THIS EVENT AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT. THERE WAS NO REPORT OF CUSTOMER INJURY OR DIRECT EXPOSURE TO THE FOAM AND BUBBLES FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251556 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1