BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIOS FLOW CYTOMETER SYSTEM

    MDR report key: 4094407 · Received September 16, 2014

    Report

    Report Number
    1061932-2014-02376
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    OYE
    PMA / PMN Number
    K130373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE NOTED THAT THE LASER CURRENT WAS HIGH AT 0.65A (AMPS), BUT THE LASER POWER OUTPUT WAS LOW AT 10MW (MILLIWATTS) WHEN DIRECTLY MEASURED. THE FSE REPLACED THE LASER AND RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VOLTAGES AND GAINS NEED TO BE REPEATEDLY CHANGED TO SEE CELL POPULATIONS ON THE GALLIOS FLOW CYTOMETER. THE GALLIOS FLOW CYTOMETER IS A NOT AN IN-VITRO DIAGNOSTIC (IVD) INSTRUMENT. 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. THERE WERE NO REPORTS OF INJURIES, ERRONEOUS RESULTS OR CHANGE IN PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. GALLIOS FLOW CYTOMETER PART NUMBER A71846 WITH SERIAL NUMBER (B)(4) WAS INVOLVED IN THIS EVENT. THE GALLIOS' INSTRUMENT DATE OF MANUFACTURE IS SEPTEMBER 15, 2009. THE SOFTWARE VERSION OF THE GALLIOS IS 1.2. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573217 NAVIOS FLOW CYTOMETER SYSTEM FLOW CYTOMETRIC REAGENTS AND ACCESSORIES. OYE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1