BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2032163 · Received March 28, 2011

    Report

    Report Number
    2122870-2011-00861
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    June 17, 2008
    Report Date
    July 3, 2008
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A SST TUBE. QC WAS WITHIN SPECIFICATIONS BEFORE AND AFTER THE EVENT. A SYSTEM CHECK WAS PERFORMED IN THE MORNING ON (B)(6) 2008 AND MET SPECIFICATIONS. CUSTOMER IS NOT QUESTIONING ANY OTHER ASSAYS OR RESULTS AND DECLINED SERVICE. TESTING AT BCI CPLS LAB WITH INTERFERENCE ELIMINATING PROTEINS HAS CONFIRMED THE EXISTENCE OF A PATIENT SOURCE INTERFERENT FOR THE SAMPLE RECEIVED FROM THE CUSTOMER. AN INTERFERENT IN THE PATIENT'S SAMPLE IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ERRONEOUS RESULTS FOR ONE PATIENT FOR TT4, T UPTAKE AND FERRITIN THAT WERE GENERATED BY THE ACCESS IMMUNOASSAY SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LAB. THE PATIENT WAS SENT TO AN ENDOCRINOLOGIST WHERE REPEAT TESTING WAS IN THE NORMAL REFERENCE RANGE. NO DEATH OR INJURY OCCURRED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR