BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® RHEUMATOID FACTOR REAGENT

    MDR report key: 2430965 · Received January 30, 2012

    Report

    Report Number
    2050012-2012-00289
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 30, 2011
    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 ISSUES WERE NOTED. THE CUSTOMER PROVIDED QC DATA, WHICH APPEAR ACCEPTABLE. THE CUSTOMER HAS NOT REPORTED ANY ISSUES WITH OTHER CHEMISTRIES OR ANY SYSTEM ERRORS. RF REAGENTS OF DIFFERENT LOT NUMBER WERE SENT TO THE CUSTOMER. ROOT CAUSE IS NOT KNOWN BUT THIS APPEARS TO BE A REAGENT ISSUE. ROOT CAUSE INVESTIGATION IS ONGOING.

    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 AND (B)(6) 2011 FOR EIGHT (8) PATIENT SAMPLES. IMMAGE RHEUMATOID FACTOR REAGENT LOT M101865 WAS USED FOR THE ASSAYS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE PATIENTS' SAMPLES PRODUCED NEGATIVE RESULTS WITH THE PREVIOUS LOT OF RF REAGENT. THERE WAS NO CHANGE TO PATIENT TREATMENT. THIS REPORT DOCUMENTS THE EVENT OCCURRED ON (B)(6) 2011. THE EVENT ON (B)(6) 2011 IS DOCUMENTED IN MDR #2050012-2012-00288. IMMAGE 800 IMMUNOCHEMISTRY SYSTEM: CATALOGUE NUMBER - A15445, SERIAL NUMBER - (B)(4), DATE OF MANUFACTURE - 04/03/2009, PRODUCT CODE - NEPHELOMETER, FOR CLINICAL USE, 510(K) NUMBER - K962294.

    Description of Event or Problem · 1

    THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, BUT THERE WAS NO CHANGE TO PATIENT TREATMENT.

    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