BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY (REMANUFACTURED)

    MDR report key: 2494966 · Received March 16, 2012

    Report

    Report Number
    2122870-2012-00782
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 17, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT SAMPLING DETAILS WERE NOT SUPPLIED BY THE CUSTOMER TO DATE. THE CUSTOMER INDICATED THAT FREE T4 QC WAS WITHIN RANGE DURING THE TIME OF THE EVENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT; HOWEVER, NO DETAILS WERE PROVIDED TO DATE. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THE FOLLOWING MDRS LISTED BELOW INCLUDES THE COMPLETE LIST OF REPORTS SUBMITTED FOR THIS EVENT THAT OCCURRED AT THIS CUSTOMER SITE: 2122870-2012-00773, 2122870-2012-00782, 2122870-2012-00783, 2122870-2012-00784, 2122870-2012-00785, 2122870-2012-00786, 2122870-2012-00787, 2122870-2012-00788, 2122870-2012-00789, 2122870-2012-00790, 2122870-2012-00791, 2122870-2012-00792, 2122870-2012-00793.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING DISCREPANT FREE THYROXINE (T4) PATIENT RESULTS UPON REPEAT TESTING, GENERATED ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (REMANUFACTURED) USED IN CONJUNCTION WITH ACCESS FREE T4, 2X50 DET, REAGENT (LOT #170112). THIS EVENT OCCURRED OVER THE COURSE OF SEVERAL DAYS, RANGING FROM (B)(6) 2012. THIS REPORT DOCUMENTS THE RESULTS OBTAINED ON (B)(6) 2012. THE CUSTOMER INDICATED THAT MANY OF THE REPEATED FREE T4 SAMPLES WERE ABOVE THE 10% IMPRECISION CONTROL VOLUME (CV) WITHIN THE FREE T4 INSTRUCTIONS FOR USE (IFU). SOME OF THE REPEATED RESULTS ALSO CROSSED CLINICALLY SIGNIFICANT CATEGORIES. 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 (REMANUFACTURED) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXI 800 (REMANUFACTURED) NA

    Patients

    Seq Age Sex Outcome Treatment
    1