BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2250475 · Received September 15, 2011

    Report

    Report Number
    2122870-2011-03653
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 19, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION, CENTRIFUGATION, SYSTEM CHECK OR QC DATA WAS NOT SUPPLIED THE SAMPLES WERE SENT TO BEC CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR TESTING AND CPLS TESTING CONFIRMED THE PATIENT RESULTS OBTAINED BY THE CUSTOMER. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THIS REPORT DOCUMENTS THE FRT3 RESULTS FOR THIS PATIENT'S SAMPLE RUN ON (B)(6) 2011. THE FREE T4 (FRT4) RESULTS FOR THIS PATIENT'S SAMPLE RUN ON (B)(6) 2011 HAVE BEEN DOCUMENTED IN MDR#2122870-2011-03655.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. REGARDING ELEVATED FREE T3 (FRT3) RESULTS ABOVE THE NORMAL REFERENCE RANGE GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. REPEAT TESTING OF THE PATIENT SAMPLE ON AN ALTERNATE METHOD PRODUCED LOWER RESULTS IN THE NORMAL REFERENCE RANGE THAT WERE DISCORDANT TO THE ORIGINAL RESULTS. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1