BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH500

    MDR report key: 2022883 · Received March 18, 2011

    Report

    Report Number
    1061932-2011-00153
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) REFITTED TUBING ONTO THE CENTER BSV SECTION. THE FSE RAN SEVERAL STARTUPS AND PERFORMED REPRODUCIBILITY IN BOTH MODES TO VERIFY THE REPAIR. THE FSE ALSO VALIDATED THE INSTRUMENT AND NO FURTHER LEAKS WERE OBSERVED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE RINSE BLOCK WAS LEAKING WHEN THEY RAN THEIR INSTRUMENT IN SECONDARY MODE. SAMPLE RESULTS WERE NOT REPORTED OUT FROM THE SECONDARY MODE. THE OPERATOR WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE); LAB COAT AND FACE SHIELD. THERE WAS NOT DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT AND THE OPERATOR DID NOT SEEK MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH500 AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH500

    Patients

    Seq Age Sex Outcome Treatment
    1