BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIN CHEM ALBUMIN BCG REAGENT

    MDR report key: 1991224 · Received February 15, 2011

    Report

    Report Number
    2018433-2011-00001
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 29, 2010
    Report Date
    March 18, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ARCHITECT ANALYZER, LIST #1G06-01, (B)(4). THE CAUSE OF THE PARTICULATE MATTER ((B)(4), A FUNGAL SPECIES FOUND IN THE ENVIRONMENT) OBSERVED IN SOME CLINICAL CHEMISTRY (B)(4) 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 CLINICAL CHEMISTRY ALBUMIN BCG CONTROLS OUT OF RANGE WHEN REVIEWING THE NIGHT SHIFT'S QUALITY CONTROL DATA. THE CUSTOMER DETERMINED PATIENT RESULTS WERE REPORTED OUT OF THE LAB WHEN THE ALBUMIN CONTROLS WERE OUT OF RANGE. THE CUSTOMER SENT CALIBRATION DATA, LEVY-JENNINGS DATA AND PATIENT DATA TO ABBOTT FOR EVALUATION. THE CUSTOMER SUCCESSFULLY RECALIBRATED THE ALBUMIN ASSAY WITH THE QUALITY CONTROLS WITHIN SPECIFICATION AND RE-ASSAYED PATIENT SAMPLES FROM THE RUN WITH CONTROLS OUT OF RANGE. AN EXAMPLE OF THE PATIENT DATA IS AS FOLLOWS: INITIAL RESULT: 3.1 G/DL, REPEAT RESULT: 4.3 G/DL THE INITIAL PATIENT RESULT AND A CORRECTED PATIENT RESULT WAS REPORTED 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.

    Patients

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