BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEUMATOID FACTOR

    MDR report key: 2001984 · Received February 27, 2011

    Report

    Report Number
    2050012-2011-00539
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM. QC MEAN WAS ELEVATED. SERVICE WAS NOT DISPATCHED SINCE THIS IS A REAGENT ISSUE. CHANGING REAGENT LOTS HAS RESOLVED THE ISSUE. THIS IS A REAGENT ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUS POSITIVE RHEUMATOID FACTOR RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN THE INITIAL SAMPLES WERE REPEATED USING: NEW REAGENT AND CALIBRATE LOT. NEW REAGENT AND PREVIOUS CALIBRATOR LOT. LOWER RESULTS WERE OBTAINED IN BOTH REPEAT RUNS. NO IMPACT TO PATIENT OR TO PATIENT TREATMENT OCCURRED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEUMATOID FACTOR RHEUMATOID FACTOR, DHR BECKMAN COULTER INC. RHEUMATOID FACTOR M004772//M007324

    Patients

    Seq Age Sex Outcome Treatment
    1