BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEUMATOID FACTOR TEST SYSTEM

    MDR report key: 2141885 · Received June 28, 2011

    Report

    Report Number
    2050012-2011-02569
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    N/A
    Removal / Correction Number
    2050012-06/24/2011-024R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE INFORMATION PROVIDED. PER CUSTOMER: NO SYSTEM ISSUES WERE NOTED. QC HAS BEEN ACCEPTABLE, AND DOES NOT REPORT ANY CALIBRATION ISSUES. CUSTOMER SWITCHED TO A NEW RF REAGENT LOT IN (B)(6) 2011; HOWEVER, THIS HAS NOT RESOLVED THE ISSUE. SERVICE WAS CANCELLED SINCE THIS IS A REAGENT RELATED ISSUE AND NOT INSTRUMENT HARDWARE RELATED. THIS IS A REAGENT ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO ERRONEOUS POSITIVE RHEUMATOID FACTORS (RF) RESULTS GENERATED BY UNICEL DXC 800 PRO CHEMISTRY ANALYZER USING RF REAGENT LOT M009630 FOR UNKNOWN NUMBER OF PATIENTS SINCE (B)(6) 2010. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. CUSTOMER PROVIDED DATA SHOWS THE NUMBER OF PATIENTS IN THE FOLLOWING RANGES: <20.0, 20-30, AND >30 (IU/ML) FOR THE MONTHS FROM (B)(6) 2010 TO (B)(6) 2011. THESE DATA INDICATED THAT THE NUMBER OF PATIENTS IN THE 20-30 RANGE INCREASED FROM AN AVERAGE OF 26.5 PER MONTH IN (B)(6) - (B)(6) 2010, TO AN AVERAGE OF 104.2 PER MONTH IN (B)(6) 2010 - (B)(6) 2011. PER CUSTOMER, NO REPORTS OF AFFECTS TO PATIENT TREATMENT, ONLY THAT PATIENTS HAVE BEEN REFERRED TO RHEUMATOLOGISTS UNNECESSARILY. THIS MDR IS RELATED TO A PREVIOUSLY FILED MDR 2050012-2011-01882.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEUMATOID FACTOR TEST SYSTEM RHEUMATOID FACTOR DHR BECKMAN COULTER INC. RHEUMATOID FACTORS M009630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other