BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER

    MDR report key: 11088277 · Received December 29, 2020

    Report

    Report Number
    2122870-2020-00099
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 19, 2020
    Report Date
    December 29, 2020
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590265373
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FULL IDENTIFIER IS CASE: (B)(4). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THERE WAS NO PATIENT INVOLVEMENT IN ASSOCIATION WITH THIS EVENT. THE UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (DXI) WAS NOT RETURNED FOR EVALUATION. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS INSTRUMENT PERFORMANCE. THE CUSTOMER ALSO REPORTED THE FIRE DEPARTMENT AND THE HOSPITAL ELECTRICAL DEPARTMENT WERE CONSULTED. THE FSE DETERMINED THERE WAS AN ELECTRICAL SHORT IN THE CUSTOMER'S ELECTRICAL LINES AND THE DXI POWER SUPPLY WAS DAMAGED DUE TO THE SHORT. THE FSE REPLACED THE DXI POWER SUPPLY AS WELL AS THE DXI USER INTERFACE DISPLAY. FSE RESET THE DXI AND CONFIRMED NO FURTHER ISSUES WERE FOUND. IN CONCLUSION, THE CAUSE OF THIS EVENT IS A SHORT IN THE CUSTOMER'S ELECTRICAL LINES WHICH CAUSED THE DXI POWER SUPPLY TO SHORT OUT.

    Description of Event or Problem · 1

    ON (B)(6) 2020 THE CUSTOMER REPORTED THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (DX), PART NUMBER 973100 AND SERIAL NUMBER (B)(4), POWER SUPPLY UNIT BEGAN EMITTING SMOKE AND A BURNING SMELL. THERE WAS NO REPORT OF INJURY OR FURTHER DAMAGE TO PROPERTY DUE TO THIS EVENT. THE CUSTOMER INFORMED BECKMAN COULTER THAT THE FIRE DEPARTMENT AND THE HOSPITAL ELECTRICAL DEPARTMENT WERE NOTIFIED AND CALLED TO THE SITE. THE CUSTOMER ALSO REQUESTED THAT A BECKMAN COULTER FIELD SERVICE ENGINEER BE DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552363 UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER UNICEL DXI 800 ACCESS IMMUNO ANALY 15099590265373

    Patients

    Seq Age Sex Outcome Treatment
    1