BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-COUNT COULTER FLUOROSPHERES

    MDR report key: 3982219 · Received August 5, 2014

    Report

    Report Number
    1061932-2014-01872
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K954688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE FLOW-COUNT COULTER FLUOROSPHERES DEVICE WAS RETURNED FOR EVALUATION. THE FIELD SERVICE ENGINEER (FSE) COMPLETED SYSTEM VERIFICATION AND NOTED THE INSTRUMENT WAS IN NORMAL OPERATION. NO INSTRUMENT ISSUES WERE OBSERVED. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, A DEFINITIVE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED WHILE PERFORMING THE AUTOSET UP, THE FLOW-COUNT WAS RUNNING SMUDGE TO THE LEFT BOTTOM CORNER OF THE CALL FACTOR REGION DURING QUALITY CONTROL INVOLVING THE FLOW-COUNT COULTER FLUOROPHORES. THE CUSTOMER STATED THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED; PATIENT SAMPLES WERE NOT ANALYZED AT THE TIME OF THE EVENT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457294 FLOW-COUNT COULTER FLUOROSPHERES COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA 7548146F

    Patients

    Seq Age Sex Outcome Treatment
    1