BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 3982218 · Received August 5, 2014

    Report

    Report Number
    2122870-2014-00558
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED MULTIPLE FAILED SYSTEM CHECKS ON THE WASHED PORTION. THE FSE REPLACED THE PERISTALTIC PUMP TUBING, THE DUCKBILL, CLEANED THE WASH PUMP CERAMIC VALVES, PERFORMED ASPIRATE PLATE ALIGNMENTS, AND VERIFIED PROPER ASPIRATION AND DISPENSE. THE FSE THEN PERFORMED 38 REPETITIONS OF LUMWASH WITH NO FLIERS NOTED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE INTERMITTENT PTHIO CONTROL FAILURES AND FAILED SYSTEM CHECK DIAGNOSTIC IS ATTRIBUTED TO THE PERISTALTIC PUMP TUBING. A DEFINITIVE CAUSE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT PARATHYROID HORMONE (PTHIO) CONTROL FAILURES AND SYSTEM CHECK FAILED THE WASHED PORTION WITH PERCENT COEFFICIENT OF VARIATION (%CV) OF 61% INVOLVING THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER INDICATED PTHIO PATIENT RESULTS WERE NOT QUESTIONED OR IMPACTED. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPLACED THE ASPIRATE PROBES BUT SYSTEM CHECK CONTINUED TO FAIL. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456905 UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1