BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEUMATOID FACTOR TEST SYSTEM

    MDR report key: 2152766 · Received July 7, 2011

    Report

    Report Number
    2050012-2011-02894
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    K971788
    Removal / Correction Number
    2050012-06/24/2011-024R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE PREPARATION AND HANDLING INFORMATION ASSOCIATED WITH THIS EVENT WERE NOT SUPPLIED BY THE CUSTOMER. SYSTEM INFORMATION WAS NOT PROVIDED. CALIBRATION REPORTS AND QC CHARTS WERE NOT PROVIDED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT, AS IT APPEARS TO BE A REAGENT RELATED ISSUE. A CUSTOMER NOTIFICATION LETTER HAS BEEN DISTRIBUTED IN ASSOCIATION WITH THESE RHEUMATOID FACTOR LOT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO RHEUMATOID FACTOR (RF) ASSAY RESULTS ABOVE THE CUT OFF VALUE OF (< 20 IU/ML) GENERATED BY THE SYNCHRON LX 20 PRO CLINICAL CHEMISTRY SYSTEM ON MULTIPLE NUMBER OF PATIENTS IN ASSOCIATION WITH A SPECIFIC RHEUMATOID FACTOR (RF) REAGENT LOT. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT PROVIDE NUMBER OF PATIENTS INVOLVED AND ANY CONFIRMATORY TESTING INFORMATION. PER CUSTOMER, PATIENT DATA ARE NOT AVAILABLE, DIFFICULT TO OBTAIN FROM THE LIS SYSTEM DATABASE. PER CUSTOMER 95 % OF THE PATIENT RESULTS SHOULD FALL WITHIN THE REFERENCE RANGE. NO INDICATION FROM THE CUSTOMER THAT PATIENT TREATMENT WAS ADVERSELY AFFECTED BASED ON THE SLIGHTLY ELEVATED RF RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1