BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 4173730 · Received October 15, 2014

    Report

    Report Number
    1061932-2014-02603
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09/18/2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND CONFIRMED HIGH MEAN CELL VOLUME (MCV) RESULTS ALONG WITH AN ERROR CONDITION OF VOTE OUT (NON-NUMERIC TEST RESULTS) FOR WHITE BLOOD CELL (WBC) AND RED BLOOD CELL (RBC) PARAMETERS. THERE WERE BUBBLES IN THE WBC DILUENT DISPENSER AND THE RINSING TO THE WBC BATH WAS NOT ADEQUATE. THE WBC DILUENT DISPENSER WAS REPLACED, RESOLVING THE EVENT. BECKMAN COULTER (BEC) INTERNAL IDENTIFIER FOR THE REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RESULTS FOR THE MEAN CELL VOLUME (MCV) AND MEAN CELL HEMOGLOBIN CONCENTRATION (MCHC) WERE ERRONEOUSLY HIGH WHEN USING THE COULTER LH 780 HEMATOLOGY ANALYZER. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS REPORTED OUT OF THE LABORATORY ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655944 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1