BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH750 SLIDEMAKER

    MDR report key: 2502604 · Received March 23, 2012

    Report

    Report Number
    1061932-2012-00973
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    February 29, 2012
    Report Date
    February 29, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE PROBE DISPENSER OF THE LH750 SLIDEMAKER. THE CUSTOMER NOTED THAT THE ISSUE HAPPENED DURING THE RINSE CYCLE AND BLOOD WAS ALSO OBSERVED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LAB COAT DURING THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. PATIENT RESULTS WERE NOT AFFECTED AND THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE SOURCE OF THE LEAK WAS THE TUBING WHICH CARRIES WASTE FROM THE RINSE CUP. FSE REPLACED THE TUBING AND THERE WAS NO FURTHER EVIDENCE OF LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LH750 SLIDEMAKER SPINNER, SLIDE, AUTOMATED GKJ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1