BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 4183140 · Received October 17, 2014

    Report

    Report Number
    1061932-2014-02639
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE EVALUATED THE INSTRUMENT AND DISCOVERED THAT THE LIGHT SCATTER SENSOR WAS DEFECTIVE. THE FSE PROCEEDED TO REPLACE THE LIGHT SCATTER SENSOR AND ALIGNED THE FLOW CELL TO RESOLVE THE REPORTED ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE LIGHT SCATTER SENSOR WAS RETURNED TO BECKMAN COULTER FOR ANALYSIS AND INVESTIGATION REVEALED THAT THE SCATTER SENSOR HAD VISIBLE FOREIGN SURFACE PARTICLES, BUT NO PHYSICAL DAMAGE. FURTHER INVESTIGATION REVEALED THAT THE RETURNED PART PASSED THE RETIC LATRON TEST AND TESTING COULD NOT DUPLICATE THE REPORTED FAILURE OF LOW SCATTER RESULTS ON RETIC LATRON CONTROL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING LOW SCATTER RESULTS FOR RETIC LATRON CONTROLS RAN ON THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO REPORT OF ANY CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660230 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1