BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC 500 FLOW CYTOMETER

    MDR report key: 15982324 · Received December 14, 2022

    Report

    Report Number
    1061932-2022-00075
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    December 12, 2022
    Report Date
    February 22, 2024
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION IS NOT APPLICABLE. THERE WAS NO IMPACT TO PATIENTS AS A RESULT OF THIS EVENT. WHILE THE FSE WAS SERVICING THE INSTRUMENT FOR AN UNRELATED ISSUE, HE OBSERVED THAT THE TARPON XL AMP ASSEMBLY AT THE FLUORESCENCE CHANNEL (FL2 AND FL3) POSITIONS WAS DEFECTIVE. TO RESOLVE THE ISSUE THE FSE REPLACED THE BOARD AT THE IDENTIFIED POSITIONS. 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).

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 01- CORRECTION FIELD G3 DATE RECEIVED BY MANUFACTURER REVISED TO REFLECT CORRECT DATE OF AWARENESS BY BEC. BEC INTERNAL IDENTIFIED - (B)(4).

    Description of Event or Problem · 0

    THE FIELD SERVICE ENGINEER (FSE) REPORTED SIGNAL SHIFT AT FL2 AND FL3 POSITIONS ON THE FC500 FLOW CYTOMETER WHILE RUNNING FLOW CHECK CONTROL WHILE SERVICING THE INSTRUMENT. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474901 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 NA Unknown