BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2012523 · Received March 10, 2011

    Report

    Report Number
    2122870-2011-00604
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FT3 SAMPLES ARE COLLECTED IN PLASTIC BD LIHEP PLASMA TUBES WITH A GEL SEPARATOR. PER CUSTOMER, THE SAMPLES WERE NORMAL IN APPEARANCE AND WERE ANALYZED FROM THE PRIMARY CONTAINERS. ALL THREE LEVELS OF FT3 QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND ON THE DAY OF THE EVENT. ON (B)(6) 2011, THE CUSTOMER PERFORMED ROUTINE SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. PER CUSTOMER EVENT LOG, NO ERRORS WERE POSTED IN CONJUNCTION WITH THE RESULTS IN THIS EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO LOWER THAN EXPECTED FREE T3 (FT3) RESULTS BELOW THE NORMAL REFERENCE RANGE FOR SEVEN PATIENTS GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN SINCE THEY DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. 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 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1