BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3933000 · Received July 14, 2014

    Report

    Report Number
    1061932-2014-01604
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT AND OBSERVED THE LEAK WAS CAUSED BY THE APERTURE HOUSING, WHICH WAS NOT SEATED PROPERLY. THE FSE ADJUSTED THE APERTURE HOUSING TO RESOLVE THE LEAK. TO RESOLVE THE HGB VOTEOUTS, THE FSE CLEANED THE HGB CUVETTES. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COULTER LH 780 HEMATOLOGY ANALYZER GENERATED HEMOGLOBIN (HGB) VOTEOUTS. WHILE TROUBLESHOOTING THE INSTRUMENT, THE CUSTOMER STATED THERE WAS A LEAK FROM AN UNKNOWN LOCATION INSIDE THE INSTRUMENT. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT OPERATOR WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE LEAK. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO THE LEAK OR OF INJURY IN CONNECTION WITH THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED OR IMPACT TO PATIENT TREATMENT AS A RESULT OF THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410791 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1