BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2416229 · Received January 13, 2012

    Report

    Report Number
    2050012-2012-00047
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS INCIDENT. ROOT CAUSE IS NOT KNOWN BUT THIS APPEARS TO BE A REAGENT ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 FALSE POSITIVE RHEUMATOID FACTOR (RF) PATIENT RESULTS, ASSOCIATED WITH THE USE OF A SPECIFIC IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT LOT, WERE GENERATED ON AN IMMAGE IMMUNOCHEMISTRY SYSTEM. IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT LOT M101865 WAS IN USE ON THIS INSTRUMENT AT THE TIME OF THE EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA REVEALED THE GENERATION OF NINE POSITIVE RF PATIENT RESULTS. NO CONFIRMATORY REPEAT RF TESTING WAS PROVIDED BY THE CUSTOMER. THE ERRONEOUS RF RESULTS WERE REPORTED OUT OF THE LABORATORY, HOWEVER A PHYSICIAN QUESTIONED THE RESULTS AS THEY DID NOT CORRELATED TO PATIENTS' CONDITIONS. THERE WERE NO REPORTS OF DEATHS, SERIOUS INJURIES OR CHANGE TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. NO ISSUES WITH OTHER CHEMISTRIES OR SYSTEM ERRORS WERE REPORTED. INSTRUMENT CHEMISTRY CONTROLS WERE FOUND TO BE ACCEPTABLE DURING THE TIMEFRAME OF THIS EVENT. NO SAMPLE ISSUES WERE NOTED. NO ADDITIONAL SAMPLE HANDLING/COLLECTION INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE IMMUNOCHEMISTRY SYSTEM EPHELOMETER, FOR CLINICAL USE DHR BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR