BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3103437 · Received May 9, 2013

    Report

    Report Number
    1061932-2013-00769
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER OVER THE PHONE AND THEY FOUND THAT THE VACUUM TRAP WAS FULL OF CLEANER AND THE LYSE S III HAD A GREEN TINT TO IT. THE CTS ADVISED THE CUSTOMER TO EMPTY THE VACUUM TRAP AND INSTALL NEW LYSE S III REAGENT. IT IS UNKNOWN WHAT CAUSED THE VACUUM TRAP TO FILL WITH CLEANER. THE CUSTOMER CALLED BACK STATING THE LH500 WAS STILL GIVING THE FLOW CELL CLOG ERRORS AND REQUESTED SERVICE. BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND DID NOT FIND AN ACTIVE LEAK OR OBSERVE ANY SIGNS OF LEAKAGE. THE FSE RAN LATRON PRIMER AND OBSERVED NO LATRON WAS COMING INTO THE DIFFERENTIAL MIXING CHAMBER. UPON FURTHER INSPECTION, THE FSE DISCOVERED A PLUG IN THE MANUAL ASPIRATE PROBE WHICH WAS REMOVED TO RESOLVE THIS ISSUE. FAILURE MODE WAS RELATED TO A PLUG IN THE MANUAL ASPIRATE PROBE. HOWEVER, THE INSTRUMENT GENERATED FLOW CELL CLOG ERRORS TO ALERT THE CUSTOMER TO AN INSTRUMENT PROBLEM. (B)(4) .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT THEY NOTED ABOUT ONE HALF A CUP OF GREEN FLUID UNDER THEIR COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER ALSO REPORTED THAT ONE SAMPLE DID NOT GET DIFFERENTIAL RESULTS AND THE INSTRUMENT GENERATED FLOW CELL CLOG ERRORS. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING A LABORATORY COAT AND GLOVES. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203356 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1