BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH SLIDEMAKER

    MDR report key: 2470328 · Received February 27, 2012

    Report

    Report Number
    1061932-2012-00638
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 2, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT APPROXIMATELY 5 ML OF CLEAR FLUID LEAKED FROM THE COULTER LH750 SLIDEMAKER. CUSTOMER REPORTED THAT RETRACTION FAIL ERRORS WERE ALSO OCCURRING. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND A LEAK AT THE INTERNAL QUICK DISCONNECT ON THE LEFT TRAY. THE FSE REPLACED THE QUICK DISCONNECT AND RESOLVED THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH SLIDEMAKER SPINNER, SLIDE, AUTOMATED GKJ BECKMAN COULTER, INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1