BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC 500 FLOW CYTOMETER

    MDR report key: 13690668 · Received March 8, 2022

    Report

    Report Number
    1061932-2022-00014
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 10, 2022
    Report Date
    March 7, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    UDI-DI
    15099590572839
    PMA / PMN Number
    K071681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. THE FIELD SERVICE ENGINEER (FSE) CALIBRATED ALL THE TARPON AMP BOARDS TO RESOLVE THE ISSUE. BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CD45 NEGATIVE POPULATION AT FL1 AND FL2 WAS POSITIVE ON LOW CELLULARITY SPECIMENS ON THEIR FC 500 FLOW CYTOMETER. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. QUESTIONABLE RESULTS WERE NOT REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168297 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