BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® RHEUMATOID FACTOR REAGENT

    MDR report key: 2414449 · Received January 13, 2012

    Report

    Report Number
    2050012-2012-00103
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 16, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K963048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE ISSUES WERE NOTED. THE CUSTOMER PROVIDED CALIBRATION AND QC DATA WERE ACCEPTABLE. THE CUSTOMER HAS NOT REPORTED ANY ISSUES WITH OTHER CHEMISTRIES OR ANY SYSTEM ERRORS. ROOT CAUSE IS NOT KNOWN BUT THIS APPEARS TO BE A REAGENT ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT FALSE POSITIVE RHEUMATOID FACTOR (RF) RESULTS WERE OBTAINED WHEN IMMAGE RHEUMATOID FACTOR REAGENT LOT (B)(4) WAS USED ON IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE PATIENT RESULTS ARE SHOWN. THERE WAS NO CHANGE TO PATIENT TREATMENT AS THE INCORRECT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. IMMAGE 800 IMMUNOCHEMISTRY SYSTEM: CATALOGUE NUMBER - A15445, SERIAL NUMBER - (B)(4), DATE OF MANUFACTURE - 12/19/2002, PRODUCT CODE - JQX, NEPHELOMETER, FOR CLINICAL USE, 510(K) NUMBER - K962294. SIMILAR EVENTS ON (B)(6) 2011, AT THE CUSTOMER'S SITE ARE DOCUMENTED IN REPORT #2050012-2012-00102 AND 2050012-2012-00101, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® RHEUMATOID FACTOR REAGENT RHEUMATOID FACTOR TEST REAGENT DHR BECKMAN COULTER, INC. IMMAGE RF M106133

    Patients

    Seq Age Sex Outcome Treatment
    1