BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3834065 · Received May 27, 2014

    Report

    Report Number
    1061932-2014-01144
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND REPLACED THE RED BLOOD CELL (RBC) DISPENSER PUMP (PM2) TO RESOLVE THE ISSUE. THE FSE VERIFIED THE REPAIR AS PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING HEMOGLOBIN AND HEMATOCRIT (H&H) CHECK FAILED ERROR MESSAGE ON MULTIPLE SAMPLES RUN ON THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER STATED THAT SUBSEQUENT REPEAT OF THE SAME SAMPLES ON AN ALTERNATE LH 780 HEMATOLOGY ANALYZER PRODUCED LOWER RED BLOOD CELL (RBC) RESULTS WITHOUT AN H&H FLAG. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE TELEPHONE AND ADVISED THE CUSTOMER TO CHECK THE RBC DILUENT DISPENSER PUMP (PM2). THE CUSTOMER OBSERVED BUBBLES IN THE BOTTOM OF THE CHAMBER AND REQUESTED FOR SERVICE. THE CUSTOMER PROVIDED INSTRUMENT PRINTOUTS FOR FOUR (4) PATIENT SAMPLES FOR THIS EVENT. ALL FOUR (4) SAMPLE RESULTS FROM THE COULTER LH 780 HEMATOLOGY ANALYZER IN QUESTION GENERATED H&H CHECK FAILED ERROR MESSAGE. PATIENTS 1 AND 2 RECOVERED HIGHER RBC RESULTS WITH INSTRUMENT FLAGS/MESSAGES WHEN COMPARED TO RERUN RESULTS FROM THE ALTERNATE LH 780 ANALYZER WHICH THE CUSTOMER CONSIDERED TO BE CORRECT. ALL OTHER PARAMETERS, WITH THE EXCEPTION OF MEAN CORPUSCULAR VOLUME (MCV), DID NOT CORRELATE. THE CUSTOMER DID NOT PROVIDE REPEAT RESULTS FOR PATIENT 3 AND 4 WHICH WERE CONSIDERED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310949 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1