BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIOS FLOW CYTOMETER SYSTEM

    MDR report key: 4081891 · Received September 11, 2014

    Report

    Report Number
    1061932-2014-02313
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    OYE
    PMA / PMN Number
    K130373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND THE GALLIOS FLOW CYTOMETER'S SAMPLE PROBE WAS RESTRICTED AND ATTEMPTED TO CLEAN THE PROBE WITH BLEACH, BUT WAS NOT SUCCESSFUL. THE FSE REPLACED THE PROBE, CLEARING THE RESTRICTION AND RESTORING FLUID FLOW. NEXT, THE FSE MADE AN ADJUSTMENT TO THE ALIGNMENT OF THE BLUE LASER, DECREASED THE FORWARD SCATTER GAIN AND INCREASED THE VOLTAGE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ISSUES ON A GALLIOS FLOW CYTOMETER. THE CUSTOMER STATED THE FLOW CHECK BEADS WERE SHIFTING. IN ADDITION, PERCENT COEFFICIENT OF VARIATION (CVS) FOR THE RED LASER WERE FAILING AND THE CVS FOR THE BLUE LASER WERE WITHIN SPECIFICATION, BUT CLOSE TO THE CUT-OFF. THERE WERE NO ERRONEOUS RESULTS GENERATED. PATIENT TREATMENT WAS NOT IMPACTED IN CONNECTION WITH THIS EVENT. THE GALLIOS FLOW CYTOMETER IS A NOT AN IN-VITRO DIAGNOSTIC (IVD) INSTRUMENT AND IS FOR RESEARCH USE ONLY. THIS REPORT REFERENCES THE NAVIOS FLOW CYTOMETER SYSTEM WHICH IS AN IVD INSTRUMENT AND IS SIMILAR IN DESIGN AND FUNCTION TO THE GALLIOS FLOW CYTOMETER. GALLIOS FLOW CYTOMETER PART NUMBER A94292 WITH SERIAL NUMBER (B)(4), SOFTWARE VERSION 1.2, MANUFACTURED NOVEMBER 15, 2012 WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561037 NAVIOS FLOW CYTOMETER SYSTEM FLOW CYTOMETRIC REAGENTS AND ACCESSORIES OYE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1