BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT)

    MDR report key: 2213766 · Received August 17, 2011

    Report

    Report Number
    2050012-2011-04564
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    K971788
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT PROVIDED. RF QC RESULTS WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND CHECKED THE PRESSURES, VACUUM, ALIGNMENTS AND TEMPERATURES OF THE INSTRUMENT. THE FSE REPLACED THE SAMPLE AND REAGENT 3-WAY VALVES. THE FSE CALIBRATED AND RAN QC FOR RF AND WERE WITHIN RANGE. RF RESULTS OF 21 AND 22 WERE STILL SEEN AFTER SERVICING. THERE IS CURRENTLY A CAPA OPEN UNDER INVESTIGATION FOR RF REAGENT PROBLEMS SIMILAR TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING A FALSE POSITIVE RHEUMATOID FACTOR (RF) RESULT THAT WAS GENERATED BY THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE RF REFERENCE CUTOFF IS 20 IU/ML. IT IS EXPECTED THAT 95% OF PATIENT RESULTS WILL BE <20 IU/ML. THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT) RHEUMATOID FACTOR REAGENT DHR BECKMAN COULTER INC. RF REAGENT M012376

    Patients

    Seq Age Sex Outcome Treatment
    1