BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3962082 · Received July 28, 2014

    Report

    Report Number
    1061932-2014-01749
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    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

    THE CUSTOMER TROUBLESHOOTED THE INSTRUMENT WITH BECKMAN COULTER (BEC) CUSTOMER TECHNICAL SUPPORT (CTS). THE CUSTOMER LOCATED CUT TUBING AT PV37; REPLACEMENT OF TUBING AT PV37 RESOLVED THE LEAK AND THE LYSE TEMPERATURE ERRORS. BEC FIELD SERVICE WAS NOT DISPATCHED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COULTER LH 500 HEMATOLOGY ANALYZER LEAKED BLUE FLUID DURING INSTRUMENT START UP. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. IN ADDITION, THE INSTRUMENT GENERATED LYSE TEMPERATURE ERRORS. THE INSTRUMENT OPERATOR WAS WEARING GLOVES, A FACE SHIELD, AND A LAB COAT WHEN THE LEAK WAS FOUND. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED IN CONNECTION WITH THIS EVENT AND THERE WAS NO IMPACT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437847 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1