BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIN CHEM ALBUMIN BCG REAGENT

    MDR report key: 1647221 · Received March 31, 2010

    Report

    Report Number
    2018433-2010-00042
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 4, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE: ARCHITECT C8000 ANALYZER, LIST # 1G06-11, (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): ARCHITECT ANALYZER, LIST # 1G06-11, SERIAL # (B)(4). THE CAUSE OF THE PARTICULATE MATTER ((B)(6), 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 ELEVATED CLINICAL CHEMISTRY ALBUMIN BCG CONTROL VALUES AND PATIENT RESULTS THAT WERE GENERATED FROM THE ARCHITECT C8000 ANALYZER WHEN REAGENT LOT 80051HW00 WAS IN USE. THE CUSTOMER STATED THE ALBUMIN RESULTS VARIED WHEN NEW ALBUMIN REAGENT OF THE SAME LOT NUMBER WAS PUT INTO SERVICE. THE CUSTOMER RECALIBRATED THE ALBUMIN ASSAY AND RE-ASSAYED THE PATIENT SAMPLES. THE CUSTOMER PROVIDED AN EXAMPLE OF THE ELEVATED PATIENT RESULTS BEFORE AND AFTER THE ALBUMIN ASSAY RECALIBRATION. INITIAL RESULT: 5.7 G/DL, REPEAT RESULT: 4.0 G/DL. THE CUSTOMER REPORTED THE SUSPECT PATIENT RESULT OUT OF THE LAB, HOWEVER, 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 # 1G06-11| ARCHITECT C8000 ANALYZER, LIST # 1G06-11