BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3253406 · Received July 29, 2013

    Report

    Report Number
    1061932-2013-01612
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE OBSERVED THAT THE INSTRUMENT WAS GENERATING INCOMPLETE DIFFERENTIALS AND DISCOVERED A DAMAGED LINE FROM THE BOTTOM OF THE DIFFERENTIAL MIXING CHAMBER TO THE FLOW CELL. THE FSE REPLACED THE AFFECTED TUBING AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE DAMAGED TUBING FROM THE BOTTOM OF THE DIFFERENTIAL MIXING CHAMBER TO THE FLOW CELL. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING INCOMPLETE DIFFERENTIAL RESULTS FOR CONTROLS AND PATIENTS' RESULTS INVOLVING THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER ALSO INDICATED THAT MURKY FLUID LEAKED AROUND THE FLOW CELL OF THE INSTRUMENT. THE CUSTOMER STATED THAT APPROXIMATELY 1 ML OF FLUID LEAKED AND WAS CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO EXPOSURE OR INJURY REPORTED FOR THIS EVENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354174 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1