BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC 500 FLOW CYTOMETER

    MDR report key: 8187008 · Received December 20, 2018

    Report

    Report Number
    1061932-2018-01072
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    October 8, 2018
    Report Date
    December 19, 2018
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    UDI-DI
    15099590572839
    PMA / PMN Number
    K071681
    Removal / Correction Number
    2050012-0108/2018-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 REPLACED THE TARPON AMP BOARD. 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 FL3 AND FL4 MOVING AROUND THE GATING REGION ON THEIR FC 500 FLOW CYTOMETER. 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
    1026556 FC 500 FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER TN, FC500 FLOW CYTOMETER 100-240V, 50/60HZ 15099590572839

    Patients

    Seq Age Sex Outcome Treatment
    1