BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIOS FLOW CYTOMETER SYSTEM

    MDR report key: 4419740 · Received January 14, 2015

    Report

    Report Number
    1061932-2015-00071
    Event Type
    Malfunction
    Date Received
    January 14, 2015
    Date of Event
    December 18, 2014
    Report Date
    December 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    OYE
    PMA / PMN Number
    K130373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS FIELD DOES NOT APPLY, AS THIS REPORT REFERENCES THE NAVIOS FLOW CYTOMETER SYSTEM, ALL SERIAL NUMBERS. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND REPLACED THE SAMPLE PRESSURE REGULATOR RESOLVING THE PROBLEM. BECKMAN COULTER (BEC) INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    WHILE SERVICING A GALLIOS FLOW CYTOMETER, A BECKMAN COULTER FIELD SERVICE ENGINEER IDENTIFIED THE SAMPLE PRESSURE REGULATOR FAILED AT ABOUT 9 MONTHS POST INSTRUMENT INSTALL. THE FIELD SERVICE ENGINEER (FSE) NOTED THAT THE SAMPLE PRESSURE BEGAN FLUCTUATING AND BECAME UNSTABLE. NO SAMPLE PRESSURE ERROR MESSAGE WAS DISPLAYED. A BLUE LASER WARNING ERROR MESSAGE WAS DISPLAYED BUT THE UNIT DID NOT STOP. THERE WAS NO LEAK ASSOCIATED WITH THIS EVENT. THE GALLIOS FLOW CYTOMETER IS 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. THE SAMPLE PRESSURE REGULATOR THAT FAILED AND WAS REPLACED IN THE GALLIOS FLOW CYTOMETER IS A COMMON PART ON BOTH THE GALLIOS AND NAVIOS. THERE WERE NO ERRONEOUS TEST RESULTS WITH THIS EVENT. THE INSTRUMENT WAS USED FOR RESEARCH PURPOSES. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT. GALLIOS FLOW CYTOMETER PART NUMBER A94292 WITH SERIAL NUMBER (B)(4) WAS INVOLVED IN THIS EVENT. THIS GALLIOS' INSTRUMENT DATE OF MANUFACTURE IS OCTOBER 15, 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32137 NAVIOS FLOW CYTOMETER SYSTEM FLOW CYTOMETRIC REAGENTS AND ACCESSORIES OYE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1