BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3900891 · Received June 27, 2014

    Report

    Report Number
    1061932-2014-01477
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND CONFIRMED THE LS OFFSET HIGH AT 1.7 FOR DIFFERENTIAL, AND 0.7 FOR RETICULOCYTE. THE FSE REPLACED THE FLOW CELL AND SAMPLE LINES TO RESOLVE THIS ISSUE. THE FSE VERIFIED AND VALIDATED THE SYSTEM. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ERROR CONDITION OF DIFF LS OFFSET ERRORS DURING THE STARTUP PROCEDURE WHEN USING THE COULTER LH 780 HEMATOLOGY ANALYZER. THE INSTRUMENT FAILED THE STARTUP PROCEDURE. THE CUSTOMER PERFORMED MULTIPLE FLOW CELL FLUSH PROCEDURES, AND DID NOT RESOLVE THE ISSUE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE INSTRUMENT. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS 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
    376833 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1