BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2060358 · Received April 15, 2011

    Report

    Report Number
    2122870-2011-01006
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN EITHER 12X75MM, 13X100MM OR 16X100MM RED TOP SERUM TUBES, AND WERE CENTRIFUGED FOR TEN MINUTES AT 3000 RPM AT ROOM TEMPERATURE. QC HAD BEEN WITHIN THE ESTABLISHED RANGES. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. ADDITIONAL SYSTEM INFORMATION HAS NOT BEEN SUPPLIED TO DATE. SERVICE WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE TUBING FOR DISPENSE PROBE #3 HAD BEEN SEVERED. THE FSE REPLACED DISPENSE PROBE #3 AND CLEANED OUT THE WASH BUFFER SPILL FROM THE WASH ARM. THE FSE PERFORMED A ROUTINE SYSTEM CHECK, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. HARDWARE WAS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS TSH, CEA2, OV MONITOR, PTH AND HYB-PSA RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER FOR EIGHT PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED RESULTS IN EITHER A DIFFERENT CLINICAL CATEGORY OR OUTSIDE ASSAY PRECISION CLAIMS FOR ALL PATIENTS INVOLVED. THE EVENT OCCURRED BETWEEN (B)(6) 2011 AND (B)(6) 2011, AND THE CUSTOMER WAS UNSURE WHEN THE ISSUES STARTED. THIS REPORT IS SUBMITTED FOR THE EVENT ON (B)(6) 2011. A SEPARATE REPORT, #2122870-2011-01005, HAS BEEN SUBMITTED FOR THE EVENT ON (B)(6) 2011. 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 ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1