BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® RHEUMATOID FACTOR REAGENT

    MDR report key: 2386741 · Received December 22, 2011

    Report

    Report Number
    2050012-2011-08512
    Event Type
    Malfunction
    Date Received
    December 22, 2011
    Date of Event
    November 15, 2011
    Report Date
    November 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K963048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE ISSUES WERE NOTED. THE CUSTOMER DID NOT PROVIDE CALIBRATION OR QC DATA. THE CUSTOMER HAS NOT REPORTED ANY ISSUES WITH OTHER CHEMISTRIES OR ANY SYSTEM ERRORS. ROOT CAUSE IS NOT KNOWN BUT THIS APPEARS TO BE A REAGENT ISSUE. ROOT CAUSE INVESTIGATION IS ONGOING. THE CUSTOMER WAS SENT A NEW LOT OF REAGENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT RHEUMATOID FACTOR (RF) RESULTS WERE SHIFTED UP WHEN IMMAGE RHEUMATOID FACTOR REAGENT LOT M101865 WAS USED ON IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REAGENT OF A DIFFERENT LOT, M106133, PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE, BELOW 20 IU/ML. THE NUMBER OF INVOLVED PATIENTS AND SPECIFIC PATIENT RESULTS WERE NOT PROVIDED BY THE CUSTOMER. THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS EVENT. IMMAGE 800 IMMUNOCHEMISTRY SYSTEM: CATALOGUE NUMBER - A15445; SERIAL NUMBER - (B)(4); DATE OF MANUFACTURE - 04/16/2004; PRODUCT CODE - JQX, NEPHELOMETER, FOR CLINICAL USE; 510(K) NUMBER - K962294.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® RHEUMATOID FACTOR REAGENT RHEUMATOID FACTOR TEST REAGENT DHR BECKMAN COULTER, INC. IMMAGE RF M101865

    Patients

    Seq Age Sex Outcome Treatment
    1