BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUIOS CL FLOW CYTOMETRY SYSTEM

    MDR report key: 12828130 · Received November 17, 2021

    Report

    Report Number
    1061932-2021-00153
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 21, 2021
    Report Date
    November 16, 2021
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. THE APPLICATION SUPPORT SPECIALIST WORKED WITH THE CUSTOMER BUT WAS NOT ABLE TO IDENTIFY AN INSTRUMENT MALFUNCTION. THE ISSUE ONLY OCCURRED WITH A SPECIFIC BATCH OF SAMPLES. THE CUSTOMER DID NOT CALL BACK TO REPORT A RECURRENCE OF THIS EVENT. BEC INTERNAL IDENTIFIER CASE: (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCREPANT CD4 COUNTS ON THE AQUIOS CL. RESULTS WERE REVIEWED AND NOT RELEASED OUT OF THE LABORATORY. 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
    1728203 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 Unknown