BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® RHEUMATOID FACTOR REAGENT

    MDR report key: 2435553 · Received February 1, 2012

    Report

    Report Number
    2050012-2012-00305
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 6, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K963048
    Removal / Correction Number
    2050012-01/26/2012-003C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE INFORMATION WAS PROVIDED, AND NO SAMPLE ISSUES WERE NOTED. NO INFORMATION ABOUT CONTROLS, OTHER CHEMISTRIES OR SYSTEM ERRORS WAS PROVIDED. 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 ERRONEOUSLY ELEVATED RHEUMATOID FACTOR (RF) RESULTS HAD BEEN GENERATED BY IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. IMMAGE RHEUMATOID FACTOR REAGENT LOT M101865 WAS USED FOR THE ASSAYS. RF RESULTS GREATER THAN 20 IU/ML ARE CONSIDERED POSITIVE. IT IS ASSUMED THAT THE RESULTS BETWEEN 20 AND 30 IU/ML ARE FALSELY POSITIVE. RF RESULTS OVER 30 ARE NOT BEING QUESTIONED. THE CUSTOMER INDICATED THERE HAD BEEN TOO MANY RF RESULTS JUST ABOVE 20 IU/ML AND TOO FEW BELOW 20 IU/ML. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE TO PATIENT TREATMENT. IMMAGE IMMUNOCHEMISTRY SYSTEM, REFURBISHED: CATALOGUE NUMBER - A95121, SERIAL NUMBER - UNKNOWN, 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