BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2146070 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01458
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    July 1, 2007
    Report Date
    July 2, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGN
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT REQUIRED AS THE EVENT WAS ISOLATED TO A SPECIFIC PATIENT SAMPLE. HETEROPHILE INTERFERENCE. SAMPLES ARE DRAWN IN PLASTIC SERUM TUBES WITH GEL SEPARATORS AND ARE CENTRIFUGED FOR 3000 RPM FOR GREATER THAN 5 MINUTES. SYSTEM INFORMATION AND QUALITY CONTROL (QC) INFORMATION WAS NOT SUPPLIED BY THE CUSTOMER. HETEROPHILE INTERFERENCE IS THE ROOT CAUSE OF THIS EVENT. PRODUCT LABELING: FOR ASSAYS EMPLOYING MOUSE ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HUMAN ANTI-MOUSE ANTIBODIES (HAMA) IN THE SAMPLE. HUMAN ANTI-MOUSE ANTIBODIES MAY BE PRESENT IN SAMPLES FROM PATIENTS WHO HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING MONOCLONAL ANTIBODIES OR IN INDIVIDUALS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES, SUCH AS HUMAN ANTI-GOAT ANTIBODIES, MAY BE PRESENT IN PATIENT SAMPLES. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 TO (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS. RELATED MDRS: 2122870-2011-01456 AND 2122870-2011-01457.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED DISCORDANCE BETWEEN ACCESS PROGESTERONE ASSAY AND QUEST BAYER CENTAUR RESULTS FOR ONE PATIENT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THIS REPORT REFERS TO SAMPLE NUMBER THREE. THREE SAMPLES FROM THIS PATIENT WERE SENT TO BECKMAN COULTER, INC. FOR FURTHER ANALYSIS AND HETEROPHILE INTERFERENCE WAS CONFIRMED. IT IS UNKNOWN IF THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM CGN BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS PROGESTERONE ASSAY