BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT

    MDR report key: 2403120 · Received January 8, 2012

    Report

    Report Number
    2050012-2011-07350
    Event Type
    Malfunction
    Date Received
    January 8, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K963048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TECHNICAL SPECIALIST SENT CUSTOMER A REPLACEMENT RF REAGENT LOT. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES WITH THE REPLACEMENT LOT. (NOTE: THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).). SENT CUSTOMER REPLACEMENT REAGENT LOT.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM GENERATED FALSELY HIGH RHEUMATOID FACTOR (RF) RESULTS ON FOUR PATIENT SAMPLES, USING IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT LOT #M101865. CUSTOMER STATED THAT THESE RESULTS WERE NOT CONSISTENT WITH THE PATIENTS' CLINICAL PICTURES, AS THE RESULTS EXCEEDED THE REFERENCE RANGE OF 0.0 TO 20.0 INTERNATIONAL UNITS PER MILLILITER (IU/ML). CUSTOMER DID NOT STATE HARM TO PATIENTS, AND DID NOT STATE THAT PATIENT TREATMENT WAS AFFECTED. THE ISSUE APPEARS TO BE REAGENT-SPECIFIC; THEREFORE, THE CUSTOMER TECHNICAL SPECIALIST (CTS) SENT CUSTOMER A REPLACEMENT RF REAGENT LOT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1