BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC 500 FLOW CYTOMETER

    MDR report key: 8542074 · Received April 23, 2019

    Report

    Report Number
    1061932-2019-01496
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    March 27, 2019
    Report Date
    April 23, 2019
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K071681
    Removal / Correction Number
    2050012-0108/2018-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND CONFIRMED WHAT THE CUSTOMER REPORTED. TO RESOLVE THE ISSUE, THE FSE INFORMED THE CUSTOMER THAT THE SOFTWARE WILL NOTIFY FOR REVIEW IF SIGNAL DROP SIGNIFICANTLY. FSE HAD CUSTOMER RUN SAMPLES TO VERIFY FL2, FL3 SIGNAL AND ALL OK. BEC IS FILING AN MDR FOR THIS EVENT BASED ON THE FDA CLASSIFICATION OF THE 08 JAN 2018 URGENT MEDICAL DEVICE RECALL AS A CLASS I RECALL ON 20 NOV 2018 (RECALL NUMBER Z-0471-2019 FOR FC 500; RECALL NUMBER Z-0472-2019 FOR EPICS XL/XLMCL). BEC INTERNAL IDENTIFIER ¿ (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SIGNAL AT FL2 AND FL3 SOMETIMES DROP ON THEIR FC 500 FLOW CYTOMETER AND NO WARNING TO REVIEW IT. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335701 FC 500 FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER TN, FC500 FLOW CYTOMETER 100-240V, 50/60HZ

    Patients

    Seq Age Sex Outcome Treatment
    1