BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC 500 FLOW CYTOMETER

    MDR report key: 13286997 · Received January 18, 2022

    Report

    Report Number
    1061932-2022-00007
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    January 3, 2022
    Report Date
    January 18, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    UDI-DI
    15099590572822
    PMA / PMN Number
    K071681
    Removal / Correction Number
    2050012-0108/2018-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 AND SIGNAL CONDITIONER AT THE AFFECTED LOCATION (FL1). BEC IS FILING AN MDR FOR THIS EVENT BASED ON THE FDA CLASSIFICATION OF THE (B)(6) 2018 URGENT MEDICAL DEVICE RECALL AS A CLASS I RECALL ON (B)(6) 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 · 0

    THE CUSTOMER REPORTED SIGNAL DRIFT AT FL1 POSITION ON THEIR FC 500 MPL 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
    737708 FC 500 FLOW CYTOMETER COUNTER DIFFERENTIAL CELL GKZ BECKMAN COULTER TN FC500 MPL FLOW CYTOMETER 100-240V 50/60HZ 15099590572822

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown