BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT

    MDR report key: 2398197 · Received January 5, 2012

    Report

    Report Number
    2050012-2012-00008
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    December 13, 2011
    Report Date
    December 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    K963048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2011, REPORTING THAT THEY HAVE HAD 2 ERRONEOUSLY HIGH IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT RESULTS GENERATED ON AN IMMAGE 800 IMMUNOCHEMISTRY SYSTEM FOR TWO PATIENT SAMPLES WHICH WERE REPORTED OUT OF THE LAB ON (B)(6) 2011. CUSTOMER REPORTED THAT BOTH PATIENT RESULTS GENERATED RF VALUES OF 22 IU/ML BUT WERE <20 IU/ML WHEN RERUN. UPON FOLLOW-UP WITH THE CUSTOMER, THEY EXPLAINED THAT THE QC LEVEL 2 WAS OUT LOW WHEN THEY HAD RUN THE TWO PATIENT SAMPLES BUT THE TECHNICIAN DID NOT CHECK IF THE QC WAS OUT AND WAS NOT AWARE OF THE ISSUE. CUSTOMER MENTIONED THAT ONCE RF REAGENT WAS RECALIBRATED, CONTROLS AND PATIENT SAMPLES WERE RUN, THE RESULTS WERE FINE. CUSTOMER BELIEVED THAT THERE WAS NO INSTRUMENT MALFUNCTION AND THIS WAS MORE OF A REAGENT ISSUE BECAUSE RECALIBRATION OF REAGENT BROUGHT QC BACK IN RANGE. CUSTOMER REPORTED THAT NO CHANGE TO PATIENT TREATMENT WAS MADE ON THE REPORTED ERRONEOUS RESULTS. FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT AS CUSTOMER STATED THAT THE ISSUE WAS DUE TO THE QC NOT WITHIN ESTABLISHED RANGES. HOTLINE HAD REQUESTED FOR NEW LOTS OF REAGENT AND CALIBRATOR TO BE SENT TO CUSTOMER TO USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1