BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 3822286 · Received May 20, 2014

    Report

    Report Number
    2122870-2014-00390
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 27, 2014
    Report Date
    April 27, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) NOTED PREMATURE FAILURE OF THE REAGENT STORAGE GRIPPER SENSORS ON THE INSTRUMENT. THE FSE REPLACED THE REAGENT GRIPPER SENSORS AND RESOLVED THE SYSTEM ERRORS. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE GRIPPER SENSORS. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED SYSTEM ERROR MESSAGE, REAGENT PACK GRIPPER DID NOT GRIP REAGENT PACK, INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THERE WAS NO REPORT OF ERRONEOUS PATIENT RESULTS GENERATED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300800 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1