BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 1930911 · Received December 16, 2010

    Report

    Report Number
    1061932-2010-00293
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED TUBING WHICH RESOLVED THE ISSUE. THE ROOT CAUSE WAS A TUBING LEAK.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING A FLUID LEAK UNDERNEATH THE DILUTER OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE FLUID WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING PROPER PPE AT THE TIME OF THE INCIDENT AND DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1