BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 5539879 · Received March 31, 2016

    Report

    Report Number
    1061932-2016-00314
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    March 10, 2016
    Report Date
    March 10, 2016
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    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 FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON (B)(4) 2016. THE FSE FOUND THAT THE TUBING AT PINCH VALVE VL53B WAS DEFECTIVE. THE FSE REPLACED THE TUBING, WHICH REPAIRED THE LEAK. THE REPAIRS WERE VERIFIED BY THE FSE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT MODEL WAS CHANGED FROM LH500 TO LH750. THE 510(K) NUMBER WAS CHANGED FROM K042724 TO K061574.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BLUE LEAK FROM THE COULTER LH 500 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS A FEW DROPS AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BLUE LEAK FROM THE COULTER LH 750 HEMATOLOGY ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194374 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1