BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC 500 FLOW CYTOMETER

    MDR report key: 10083874 · Received May 22, 2020

    Report

    Report Number
    1061932-2020-00076
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    November 26, 2019
    Report Date
    June 8, 2020
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    UDI-DI
    15099590572853
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) HAD ORIGINALLY DOCUMENTED THEIR DEBRIEF ON THE INCORRECT INSTRUMENT ( EPICS XL FLOW CYTOMETRY SYSTEMS), AS THE INVESTIGATOR GATHERED INFORMATION FOR THEIR INVESTIGATION THE ISSUE WAS IDENTIFIED AND THE EVENT WAS CONFIRMED TO HAVE HAPPENED ON AN FC500 MPL FLOW CYTOMETER. THIS SUPPLEMENTAL IS BEING SUBMITTED TO UPDATE/CORRECT THE INSTRUMENT INFORMATION SUBMITTED IN THE ORIGINAL REPORT. ALL OTHER EVENT INFORMATION REMAINS THE SAME. FOLLOW UP 01: CORRECTED FIELDS: B5 DESCRIBE EVENT - UPDATED PROBLEM STATEMENT TO REFLECT CORRECT INSTRUMENT NAME. D1 - BRAND NAME. D4 - CATALOG NUMBER, SERIAL NUMBER, UDI. G5 - 510K NUMBER. H9 - CORRECTION/REMOVAL REPORTING NUMBER. BEC INTERNAL IDENTIFIER: (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A SIGNAL DRIFT ON THEIR FC 500 MPL FLOW CYTOMETER .

    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 AT THE FL2 LOCATION. 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 · 1

    THE CUSTOMER REPORTED A SIGNAL DRIFT ON THEIR EPICS XL FLOW CYTOMETRY SYSTEMS. 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
    547659 FC 500 FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER TN, XL FLOW CYTOMETER 100-240V, 50/60HZ 15099590572853

    Patients

    Seq Age Sex Outcome Treatment
    1