BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIN CHEM ALBUMIN BCG REAGENT

    MDR report key: 1641409 · Received March 26, 2010

    Report

    Report Number
    2018433-2010-00006
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    February 15, 2010
    Report Date
    February 15, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE: ARCHITECT C8000 ANALYZER, LIST # 1G06-01, SERIAL #, (B)(4). THE CAUSE OF THE PARTICULATE MATTER (PENICILLIUM SP, A FUNGAL SPECIES FOUND IN THE ENVIRONMENT) OBSERVED IN SOME CLINICAL CHEMISTRY ALBUMIN BCG REAGENT CARTRIDGES WAS DUE TO EXPOSURE OF THE ALBUMIN BCG FORMULA CONTAINING WEAK ANTIMICROBIAL ADDITIVE FROM NORMAL FORMULATION AND FILTERING PROCESSES DESIGNED FOR MICROBIAL GROWTH CONTROLLED CLINICAL CHEMISTRY REAGENTS. ABBOTT ISSUED A PRODUCT RECALL ADVISING CUSTOMERS TO DISCARD OR DESTROY ANY INVENTORY OF THREE AFFECTED LOTS OF CLINICAL CHEMISTRY ALBUMIN BCG REAGENTS. ABBOTT IS IDENTIFYING ALTERNATE FORMULATION FOR THE CLINICAL CHEMISTRY ALBUMIN REAGENTS THAT CONTAIN NO MERCURY.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A SHIFT IN NON-ABBOTT QUALITY CONTROLS FOR THE CLINICAL CHEMISTRY ALBUMIN BCG ASSAY. THE CUSTOMER STATED THERE WERE NO ISSUES WITH OTHER ASSAYS; PREVENTIVE AND MONTHLY MAINTENANCE WAS CURRENT. THE CUSTOMER WAS ASKED TO FAX CURRENT AND PREVIOUS CALIBRATION DATA FOR EVALUATION. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE REVIEWED THE DATA AND NOTED THE CALIBRATOR ASSAY PARAMETERS WERE NOT CONFIGURED CORRECTLY, THEREFORE, THE CUSTOMER WAS ADVISED TO UPDATE THE ASSAY PARAMETERS TO ALBUMIN PACKAGE INSERT SPECIFICATIONS. AFTER THE CUSTOMER UPDATED THE PARAMETERS, THE CONTROL RESULTS WERE AS EXPECTED AND WITHIN SPECIFICATION. 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. 80051HW00

    Patients

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