BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2334810 · Received October 21, 2011

    Report

    Report Number
    2122870-2011-04716
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    April 16, 2010
    Report Date
    April 22, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THE ARCHIVE DATA FILES PROVIDED BY THE CUSTOMER INDICATED EVIDENCE OF PACK SHARING BETWEEN THE CUSTOMER'S TWO UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED PACK LOADING AND SHARING PROTOCOLS WITH THE CUSTOMER. REAGENT PACK SHARING HAD OCCURRED AND PRODUCED ERRONEOUS RESULTS DUE TO OPERATOR ERROR. REAGENT PACK SHARING BETWEEN SYSTEMS CAN POTENTIALLY CAUSE INACCURATE RESULTS. REAGENT PACKS CANNOT BE SHARED BETWEEN SYSTEMS AS INDICATED IN THE LABELING. THE CUSTOMER ACKNOWLEDGED AND RE-EDUCATED THE OPERATORS THAT REAGENT PACK SHARING IS NOT PERMITTED ON THE ACCESS SYSTEMS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY LOW THYROID-STIMULATING HORMONE (TSH), BELOW NORMAL CLINICAL RANGE, FOR TWENTY-THREE PTS' RESULTS, INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING ON AN ALTERNATE UNICEL DXI 800 SYSTEM PRODUCED HIGHER RESULTS, IN BETTER CORRELATION WITH THE PTS' CLINICAL CONDITION. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LAB. THERE WAS NO PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER, INC. REQUESTED FOR THE CUSTOMER'S ARCHIVE DATA FILES FOR FURTHER REVIEW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS HYPERSENSITIVE HTSH