BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3053485 · Received April 11, 2013

    Report

    Report Number
    1061932-2013-00527
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE AND CONFIRMED THAT THE LEAK WAS AROUND THE FLOWCELL AND CLEANED THE LEAK WITH BLEACH SOLUTION. THE FSE REPORTED THAT THE TUBING AT THE BOTTOM OF THE FLOWCELL HAD DISCONNECTED FROM THE FITTING (FT17-E). THE FSE REPLACED THE TUBING WHICH RESOLVED THE ISSUE. THE FSE ALSO DETERMINED THAT THE LATRON LIGHT SCATTER WAS TOO LOW AND THE LASER COULD HAVE BEEN THE CAUSE. THE FSE SUBSEQUENTLY REPLACED THE LASER, FLOWCELL AND LS SENSOR WHICH RESOLVED THE ISSUE. PER THE FSE, THE LEAK DID NOT APPEAR TO BE RELATED TO THE LATRON ISSUES. THE CAUSE OF THE LEAK IS ATTRIBUTED TO THE TUBING AT FT17-E. THE CAUSE OF THE DIFFERENTIAL/RETIC LS MEAN COUNTS IS ATTRIBUTED TO THE LIGHT SCATTER PATH. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A LEAK OF APPROXIMATELY 1ML FROM THE DIFFERENTIAL MIXING CHAMBER AREA OF A COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER ALSO REPORTED THAT LATRON DIFFERENTIAL/RETIC LS (LIGHT SCATTER) MEAN COUNTS WERE OUT OF RANGE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABCOAT, GLOVES AND PROTECTIVE EYEWEAR AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154742 COULTER® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1