BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® RHEUMATOID FACTOR REAGENT

    MDR report key: 2499250 · Received March 21, 2012

    Report

    Report Number
    2050012-2012-00720
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 24, 2012
    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 INFORMATION WAS PROVIDED. QC RESULTS PROVIDED BY THE CUSTOMER APPEAR ACCEPTABLE. THE CUSTOMER INDICATED ISSUE STARTED WHEN THEY BEGAN USING RF REAGENT LOT M103174. 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 M103174 WAS USED FOR THE ASSAYS. THE CUSTOMER INDICATED THERE HAD BEEN TOO MANY RF RESULTS BETWEEN 20 IU/ML AND 25 IU/ML FOR THE PATIENTS FOR WHOM RF RESULTS BELOW 20 IU/ML WERE EXPECTED. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THERE HAD BEEN NO REPORT OF ANY CHANGE TO PATIENT TREATMENT BASED ON THE ERRONEOUSLY REPORTED RESULTS. IMMAGE 800 IMMUNOCHEMISTRY SYSTEM: CATALOGUE NUMBER - A15445, SERIAL NUMBER - (B)(4). PRODUCT CODE - JQX, NEPHELOMETER, FOR CLINICAL USE. THE 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 M103174

    Patients

    Seq Age Sex Outcome Treatment
    1