BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUIOS CL FLOW CYTOMETRY SYSTEM

    MDR report key: 10306022 · Received July 21, 2020

    Report

    Report Number
    1061932-2020-00120
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 25, 2020
    Report Date
    July 21, 2020
    Manufacturer
    BECKMAN COULTER IRELAND INC.
    Product Code
    OYE
    UDI-DI
    15099590225889
    PMA / PMN Number
    K141932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 A MALFUNCTIONING PINCH VALVE ASSEMBLY. REVIEW OF THE INSTRUMENT LOG BY THE FSE SHOW THAT THERE WERE SEVERAL CARRYOVER FAILURES FOR THE SAME DATE AND THREE ADDITIONAL FAILURES ON 19-JUNE-2020. THE CUSTOMER CLAIMS THEY WERE UNAWARE OF THE OTHER CARRYOVER FAILURES PRIOR TO THE ONE WHICH TRIGGERED THE CALL TO THE FSE. PRIOR TO THE FSE VISIT FAILED CARRYOVER RUNS WERE FOLLOWED BY PASSING CARRYOVER RUNS. THERE IS NO EVIDENCE THAT THE CUSTOMER TOOK ANY ACTION TO RESOLVE THE ISSUE BEFORE THE PASSING RUNS. THE SAMPLE CONTROLS (IMMUNOTROL) PASSED WITH NO ISSUES OR FLAGS EVEN WHEN CARRYOVER FAILED. BEC INTERNAL IDENTIFIER - CASE (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CARRYOVER FAILURE ON THEIR AQUIOS CL FLOW CYTOMETRY SYSTEM WHEN RUNNING THE CD4-PLG SYSTEM. IT IS UNKNOWN IF ERRONEOUS PATIENT RESULTS WERE GENERATED; CONFIRMATION WAS REQUESTED FROM THE CUSTOMER BUT NOT PROVIDED. THERE IS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766480 AQUIOS CL FLOW CYTOMETRY SYSTEM FLOW CYTOMETRIC REAGENTS AND ACCESSORIES. OYE BECKMAN COULTER IRELAND INC. TN,AQUIOS CL 15099590225889

    Patients

    Seq Age Sex Outcome Treatment
    1