BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 SLIDEMAKER ANALYZER

    MDR report key: 2007381 · Received March 4, 2011

    Report

    Report Number
    1061932-2011-00117
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LOQ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND FOUND THAT THE PROBE WASH DRAIN TUBING HAD COME OFF OF THE FITTING ON THE FEED THROUGH BULK HEAD. THE FSE REPLACED THE TUBING AND RESEATED THE TUBING TO THE FITTING. THE FSE VERIFIED PERFORMANCE AND NO LEAK WAS OBSERVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THERE WAS A BLOODY LEAK COMING FROM THE COULTER LH 750 SLIDEMAKER ANALYZER. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS, AND OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 SLIDEMAKER ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER LOQ BECKMAN COULTER, INC. LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1