BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEUMATOID FACTOR REAGENT

    MDR report key: 2060515 · Received April 18, 2011

    Report

    Report Number
    2050012-2011-01198
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    K962294
    Removal / Correction Number
    Z-2887-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE INFORMATION PROVIDED. NO SYSTEM ISSUES WERE NOTED. CUSTOMER NOTED THAT CALIBRATION AND QC ARE ACCEPTABLE FOR LOT M908398. THE CUSTOMER INDICATED THAT THE PERCENT OF POSITIVE RF RESULTS IS HIGHER THAN PREVIOUS REAGENT LOT NUMBER (LOT NUMBER UNKNOWN). SERVICE WAS NOT NEEDED, THIS IS A REAGENT ISSUE. CUSTOMER WILL BE PROVIDED WITH NEWER, MORE ACCEPTABLE LOTS OF REAGENT.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUS HIGH RHEUMATOID FACTOR RESULTS GENERATED BY THE IMMAGE 800 IMMUNOCHEMISTRY. THIS EVENT IS SEEN WITH A PARTICULAR LOT OF REAGENT. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. CUSTOMER INDICATED THAT THE PERCENT OF POSITIVE MAY BE 70-80%, THE RESULTS WERE ABOUT 21-24IU/ML. MOST OF THE SAMPLES ARE FROM THE GENERAL POPULATION VISITING FOR CHECK-UPS. PATIENT TREATMENT WAS NOT IMPACTED SINCE THIS EVENT.

    Description of Event or Problem · 1

    ...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEUMATOID FACTOR REAGENT SYSTEM, TEST, RHEUMATOID FACTOR DHR BECKMAN COULTER INC. RHEUMATOID FACTOR M908398

    Patients

    Seq Age Sex Outcome Treatment
    1