BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1832426 · Received September 13, 2010

    Report

    Report Number
    2122870-2010-00529
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 4, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS FT3 SAMPLES IN 13X75MM BD SERUM TUBES WITH A GEL SEPARATOR, AND CENTRIFUGES FOR 10 MINUTES AT 3000 RPM AT ROOM TEMPERATURE. (B)(4) TECHNICAL SUPPORT REVIEW OF THE INSTRUMENT LOG FILES REVEALED AN ERROR FLAG JUST PRIOR TO THE EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO CLEAR ROOT CAUSE FOR THE EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY LOW FREE T3 RESULT BELOW THE NORMAL REFERENCE RANGE GENERATED ON UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED A RESULT ABOVE THE NORMAL REFERENCE 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 ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1