BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® RHEUMATOID FACTOR REAGENT

    MDR report key: 2400592 · Received January 6, 2012

    Report

    Report Number
    2050012-2012-00032
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 6, 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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE SERUM. NO CALIBRATION OR QC ISSUES WERE NOTED. THE CUSTOMER WAS SENT ANOTHER LOT OF REAGENT. FAILURE MODE APPEARS TO BE REAGENT RELATED. THE RELATED EVENTS AT THIS CUSTOMER SITE ARE REPORTED IN BELOW LISTED MDRS: 2050012-2012-00033, 2050012-2012-00034, 2050012-2012-00035.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT ERRONEOUSLY ELEVATED RHEUMATOID FACTOR (RF) RESULTS WERE GENERATED BY IMMAGE 800 IMMUNOCHEMISTRY SYSTEM ON (B)(6) 2011. IMMAGE RHEUMATOID FACTOR REAGENT LOT M101865 WAS USED FOR THE ASSAYS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. RECALIBRATION DID NOT MAKE DIFFERENCES IN RESULTS. REPEAT TESTING AFTER RECALIBRATION WITH A NEW LOT OF RF REAGENT (LOT M106133) PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE, BELOW 20 IU/ML, FOR MOST OF THE SAMPLES. REPEAT TESTING RESULTS WERE NOT PROVIDED. THERE WAS NO REPORT OF EFFECT TO PATIENT TREATMENT. THIS REPORT DOCUMENTS THE EVENT ON (B)(6) 2011 WHEN SEVEN ERRONEOUSLY ELEVATED RESULTS WERE GENERATED. IMMAGE 800 IMMUNOCHEMISTRY SYSTEM: CATALOGUE NUMBER - A15445, SERIAL NUMBER - (B)(4), DATE OF MANUFACTURE - 04/12/2010, 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