BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC 500 FLOW CYTOMETER

    MDR report key: 12791756 · Received November 10, 2021

    Report

    Report Number
    1061932-2021-00140
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    April 29, 2021
    Report Date
    November 10, 2021
    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
    CH
    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. 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 FL2 AND FL4 LOCATIONS. UPON FURTHER REVIEW, THIS COMPLAINT WAS REASSESSED AND WILL BE REPORTED LATE AS IT WAS DETERMINED THAT THIS EVENT WAS IN SCOPE OF THE TARPON AMP BOARD RECALL. 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 - CASE-(B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AMP BOARD ERRORS AT THE FL2 AND FL4 POSITIONS WHILE RUNNING FLOW CHECK ON THEIR FC500 FLOW CYTOMETER. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. 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
    1683418 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 Unknown