BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® RHEUMATOID FACTOR (RF REAGENT)

    MDR report key: 2080780 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01494
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 8, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE CALIBRATION APPEARS TO BE ACCEPTABLE. THE CUSTOMER ALSO INDICATED THAT THE QC RESULTS WERE WITHIN THE ESTABLISHED RANGES. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THIS WAS A REAGENT RELATED ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSELY POSITIVE SYNCHRON LX RHEUMATOID FACTOR (RF) RESULTS THAT WERE GENERATED BY THE SYNCHRON LX20 PRO CLINICAL SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED IN 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 M009630

    Patients

    Seq Age Sex Outcome Treatment
    1