BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1954559 · Received January 10, 2011

    Report

    Report Number
    2122870-2011-00011
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 12, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN HOW THE PROBE BECAME BENT OR HOW LONG THE INSTRUMENT WAS RUNNING PRIOR TO THE CUSTOMER'S DISCOVERY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED A PREVENTIVE MAINTENANCE (PM) ON THE INSTRUMENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED, DURING MAINTENANCE, THAT DISPENSE PROBE #1 WAS BENT ON UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPLACED THE DISPENSE PROBE AND THEN REPEATED PREVIOUSLY ANALYZED PATIENT SAMPLES; NO ERRONEOUS RESULTS WERE OBTAINED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1