BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® RHEUMATOID FACTOR REAGENT

    MDR report key: 2402768 · Received January 6, 2012

    Report

    Report Number
    2050012-2012-00039
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 7, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE INFORMATION WAS PROVIDED. THERE WAS NO INDICATION OF PROBLEMS WITH CALIBRATION AND QC. FAILURE MODE APPEARS TO BE REAGENT RELATED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT FORTY FOUR (44) ERRONEOUSLY ELEVATED RHEUMATOID FACTOR (RF) RESULTS WERE GENERATED BY IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. IMMAGE RHEUMATOID FACTOR REAGENT LOT M101865 WAS USED FOR THE ASSAYS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER WAS SENT A DIFFERENT LOT (M106133) OF RF REAGENT, AND REPEAT TESTING WITH THIS LOT OF REAGENT PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE, BELOW 20 IU/ML. REPEAT TESTING RESULTS WERE NOT PROVIDED. THE CUSTOMER DID NOT AMEND THE PATIENT RESULT REPORTS, AND IT IS UNKNOWN IF THERE WERE ANY CHANGES TO PATIENT TREATMENT. IMMAGE 800 IMMUNOCHEMISTRY SYSTEM: CATALOGUE NUMBER - A15445, SERIAL NUMBER - (B)(4), DATE OF MANUFACTURE - 10/10/2008, PRODUCT CODE - JQX, NEPHELOMETER, FOR CLINICAL USE, 510(K) NUMBER - K962294.

    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 M101865

    Patients

    Seq Age Sex Outcome Treatment
    1