BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4092482 · Received September 16, 2014

    Report

    Report Number
    1061932-2014-02322
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TROUBLESHOOTED THE INSTRUMENT WITH BECKMAN COULTER (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) VIA TELEPHONE. THE CUSTOMER REPLACED TUBING THROUGH PINCH VALVE PV37, WHICH RESOLVED THE LEAK. BEC FIELD SERVICE WAS NOT DISPATCHED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNDETERMINED AMOUNT OF CLEANER LEAKED FROM A COULTER LH 500 HEMATOLOGY ANALYZER WHILE PERFORMING INSTRUMENT SHUTDOWN. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT OPERATOR WAS A GOWN, GLOVES, AND GOGGLES WHEN THE LEAK OCCURRED. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573381 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1