BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIN CHEM ALBUMIN BCG REAGENT

    MDR report key: 1656701 · Received April 12, 2010

    Report

    Report Number
    2018433-2010-00065
    Event Type
    Malfunction
    Date Received
    April 12, 2010
    Date of Event
    March 12, 2010
    Report Date
    March 12, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CIX
    PMA / PMN Number
    K981758
    Removal / Correction Number
    2018433-3/11/10-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS:ARCHITECT C8000 ANALYZERS, LIST # 1G06-01, (B)(4).THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVES A DIFFERENCE IN CLINICAL CHEMISTRY ALBUMIN VALUES WHEN THEY SWITCHED TO REAGENT LOT 80051HW00. THE CUSTOMER PROVIDED VERIFICATION OF THE ALBUMIN ASSAY CONFIGURATION AND CALIBRATION SET POINTS, HOWEVER, DECLINED TO CONFIGURE THE ASSAY CORRELATION FACTOR SO, ASSAY RESULTS WOULD MATCH. THE CUSTOMER STATED MAINTENANCE WAS UP TO DATE AND PROVIDED CALIBRATIONS FOR REVIEW BY ABBOTT. FROM THE CALIBRATION DATA, IT WAS DETERMINED THE CUSTOMER WAS USING THE INCORRECT SET POINTS FOR THE ALBUMIN CALIBRATORS. THE CUSTOMER PERFORMED THE RECOMMENDED TROUBLESHOOTING PROCEDURES, AND THE ISSUE WAS RESOLVED WITH THE RECONFIGURATION OF THE CALIBRATOR SET POINTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLIN CHEM ALBUMIN BCG REAGENT QUANTITATION OF ALBUMIN IN HUMAN SERUM OR PLASMA CIX ABBOTT MANUFACTURING, INC. 80051P100

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C8000 ANALYZER, LIST # 1G06-01| ARCHITECT C8000 ANALYZER, LIST # 1G06-01