BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUIOS CL FLOW CYTOMETRY SYSTEM

    MDR report key: 10256065 · Received July 9, 2020

    Report

    Report Number
    1061932-2020-00112
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    May 19, 2020
    Report Date
    July 9, 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 INFORMATION AVAILABLE REASONABLY SUGGESTS THAT THE EVENT WAS NOT A RESULT OF A MALFUNCTION OF THE AQUIOS CL INSTRUMENT. THE EVENT WAS CAUSED BY A FAULT FROM THE FACILITY SUPPLY CIRCUIT TO THE INSTRUMENT AND THE SPECIALIST RECEIVED A SHOCK WHEN TOUCHING THE INSTRUMENT DUE TO THE EXPOSURE TO LINE VOLTAGE. ALTHOUGH THE EVENT WAS NOT A DIRECT RESULT OF A BECKMAN COULTER DEVICE MALFUNCTION, BEC IS SUBMITTING A REPORT IN AN ABUNDANCE OF CAUTION. BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 1

    THERE WAS A LOSS OF GROUND RESULTING IN AN ELECTRICAL SHOCK TO A TECHNICAL SUPPORT SPECIALIST WHO WAS ASSISTING THE FIELD SERVICE ENGINEER DURING TROUBLESHOOTING ON AN AQUIOS CL. THE TECHNICAL SUPPORT SPECIALIST DID NOT REQUIRE MEDICAL ATTENTION AS A CONSEQUENCE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719439 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