BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIOS EX FLOW CYTOMETER

    MDR report key: 12708852 · Received October 27, 2021

    Report

    Report Number
    1061932-2021-00123
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    September 28, 2021
    Report Date
    October 27, 2021
    Manufacturer
    BECKMAN COULTER IRELAND INC
    Product Code
    OYE
    UDI-DI
    15099590677466
    PMA / PMN Number
    K162897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION AVAILABLE WAS NOT ENOUGH TO DETERMINE THE CAUSE OF THE REPORTED ISSUE. THE BEC APPLICATION SPECIALIST REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER MULTIPLE TIMES BUT THE INFORMATION WAS NOT PROVIDED. THE FOLLOWING IS WHAT IS KNOWN: THERE WAS NO ISSUE WITH CD45 AT THE FL1 POSITION, BUT THE 45 POSITIVITY USING CLEARLLAB COULD NOT BE DISTINGUISHED WHEN IT COULD BE DISTINGUISHED ON ANOTHER FLOW-CYTOMETER. O THE CUSTOMER IS USING CLEARLLAB REAGENT AND CLEARLLAB 10C PANELS. O PEDIATRIC B CELL-ALL AND PLASMA CELL DYSCASIAS WERE DIFFICULT TO ASSESS WITH CD45-KO(KROME ORANGE) O THE INSTRUMENT WAS PASSING FLOW-CHECK PRO AND FLOW-SET PRO. BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CLEARLAB 45 POPULATION WAS TOO BRIGHT ON ALL LOST AND ALL 4 TUBES, AND WAS NOT ABLE TO DISTINGUISH CD NEGATIVE, MODERATE, BRIGHT AT THE FL10 POSITION ON THE NAVIOS EX INSTRUMENT. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUTSIDE OF THE LAB. THERE WAS NO REPORT DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604791 NAVIOS EX FLOW CYTOMETER FLOW CYTOMETRIC REAGENTS AND ACCESSORIES. OYE BECKMAN COULTER IRELAND INC TN,NAVIOS EX 10 COLORS/3 LASERS 15099590677466

    Patients

    Seq Age Sex Outcome Treatment
    1