BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® RHEUMATOID FACTOR REAGENT

    MDR report key: 2400782 · Received January 6, 2012

    Report

    Report Number
    2050012-2012-00037
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    November 29, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE INFORMATION WAS PROVIDED. THE CUSTOMER CLAIMED QC WAS WITHIN THE ESTABLISHED RANGES. THE CUSTOMER WAS SENT ANOTHER LOT OF REAGENT (LOT M103174) FAILURE MODE APPEARS TO BE THE CALIBRATION OF THE REAGENT LOT, M012376. THE RELATED EVENTS AT THIS CUSTOMER SITE ARE REPORTED IN BELOW LISTED MDRS: 2050012-2012-00036, 2050012-2012-00038.

    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 M012376 WAS USED FOR THE ASSAYS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING AFTER RECALIBRATION WITH THE SAME LOT OF RF REAGENT PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE, BELOW 20 IU/ML. 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 ONE (1) ERRONEOUSLY ELEVATED RESULT WAS GENERATED. IMMAGE 800 IMMUNOCHEMISTRY SYSTEM: CATALOGUE NUMBER - A15445, SERIAL NUMBER - (B)(4), DATE OF MANUFACTURE - 08/18/2005, 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 M012376

    Patients

    Seq Age Sex Outcome Treatment
    1