BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1935049 · Received December 22, 2010

    Report

    Report Number
    2122870-2010-00954
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER SUPPLIED QC CHARTS, BOTH LEVELS OF TSH QC HAVE BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGE FOR THE PAST 14 DAYS. PER THE CUSTOMER SUPPLIED DOCUMENTATION, A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER SENT SAMPLE TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING. RESULTS OF THAT TESTING ARE NOT AVAILABLE TO DATE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING A HIGHER THAN EXPECTED TSH RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. HOWEVER, SUBSEQUENT TESTING ON TWO ALTERNATE METHODOLOGIES PRODUCED DISCORDANT LOWER RESULTS WITHIN A DIFFERENCE CLINICAL RANGE. 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. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1