BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2011643 · Received March 9, 2011

    Report

    Report Number
    2122870-2011-00520
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THERE WAS NO SAMPLE AVAILABLE FOR TESTING IN CUSTOMER PRODUCT LINE SUPPORT (CPLS). QC WAS RECOVERING +/-2SD OF THE CUSTOMER'S ESTABLISHED MEAN PRIOR TO AND ON THE DAY OF EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED WITH THE DATA SUPPLIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING OBTAINING HIGHER THAN EXPECTED RESULT FOR HYBRITECH PROSTATE SPECIFIC ANTIGEN (PSA) THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE POST-PROSTATECTOMY PATIENT THAT WAS DISCORDANT TO AN ALTERNATE METHOD. THE CUSTOMER REPEATED THE SAMPLE USING A HETEROPHILE BLOCKING TUBE AND RECOVERED A LOWER RESULT THAT FIT THE PATIENT'S CLINICAL PICTURE. THE RESULT WAS NOT REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT REPORT EFFECT TO THE PATIENT OR USER 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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1