BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2174175 · Received July 24, 2011

    Report

    Report Number
    2050012-2011-03399
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQX
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REAGENT LOT CHANGED. DISCREPANT PATIENT RESULTS AND A SHIFT OF QUALITY CONTROL RESULTS WERE OBTAINED. A DEFINITIVE ROOT CAUSE FOR THE EVENT HAS NOT YET BEEN DETERMINED. THE CUSTOMER INITIALLY CONTACTED BCI ON (B)(6) 2011 TO REPORT THE SHIFT IN QUALITY CONTROL RESULTS FOR RF. THE CUSTOMER FOLLOWED UP WITH A SUBSEQUENT COMMUNICATION ON (B)(6) 2011 TO REPORT THE DISCREPANT PATIENT RESULTS FOR RF.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT DISCREPANT PATIENT SAMPLE RESULTS AND A SHIFT IN QUALITY CONTROL RESULTS FOR RHEUMATOID FACTOR (RF) ASSAYED ON AN IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF THERE WAS AN IMPACT TO PATIENT TREATMENT DUE TO THE DISCREPANT RF RESULTS. THE CUSTOMER REPORTED DISCREPANT RF PATIENT RESULTS FOR ONE SAMPLE WHEN SWITCHING FROM RF REAGENT LOT # M101863 TO RF REAGENT LOT # M007630. THE CUSTOMER REPORTED THAT QUALITY CONTROL RESULTS SHIFTED LOW AND WERE OUTSIDE OF THE LABORATORY'S ESTABLISHED RANGE WHEN SWITCHING TO RF REAGENT LOT # M007630. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM NEPHELOMETER FOR CLINICAL USE JQX BECKMAN COULTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 RF (RHEUMATOID FACTOR) REAGENT