BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEUMATOID FACTOR REAGENT

    MDR report key: 2325146 · Received November 4, 2011

    Report

    Report Number
    2050012-2011-07025
    Event Type
    Malfunction
    Date Received
    November 4, 2011
    Date of Event
    September 30, 2011
    Report Date
    October 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K963048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: CUSTOMER REPORTED THAT BOTH QC AND PATIENT RESULTS IMPROVED AFTER A NEW LOT OF REAGENT AND A NEW LOT OF BUFFER WAS USED. IT IS UNCLEAR WHICH LOT CHANGE IS RESPONSIBLE FOR THE IMPROVEMENT OF RESULTS. THE ROOT CAUSE IS NOT KNOWN, BUT APPEARS TO BE A REAGENT ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT BIO-RAD QUALITY CONTROL (QC) RESULTS HAD SHIFTED UP WITH RF REAGENT LOT M106133. CUSTOMER REPORTED THE RESULTS WERE GENERATED ON THE IMAGE IMMUNOCHEMISTRY SYSTEM. BEC CUSTOMER TECHNICAL SPECIALIST ADVISED THE CUSTOMER TRY BEC CONTROLS AND A NEW LOT OF REAGENT (LOT M101865) AS WELL AS A NEW LOT OF BUFFER. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. CUSTOMER REPORTED THAT BOTH QC AND PATIENT RESULTS IMPROVED AFTER A NEW LOT OF REAGENT AND A NEW LOT OF BUFFER WAS USED. IT IS UNCLEAR WHICH LOT CHANGE IS RESPONSIBLE FOR THE IMPROVEMENT OF RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEUMATOID FACTOR REAGENT SYSTEM, TEST, RHEUMATOID FACTOR DHR BECKMAN COULTER, INC. M106133

    Patients

    Seq Age Sex Outcome Treatment
    1