BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIN CHEM ALBUMIN BCG REAGENT

    MDR report key: 1645467 · Received March 30, 2010

    Report

    Report Number
    2018433-2010-00017
    Event Type
    Malfunction
    Date Received
    March 30, 2010
    Date of Event
    January 21, 2010
    Report Date
    January 22, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ARCHITECT C16000 ANALYZER, LIST # 3L77-01, (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 C16000 ANALYZER, LIST # 3L77-01, (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 REPORTED FURTHER EXAMPLES OF CLINICAL CHEMISTRY ALBUMIN BCG REAGENT CARTRIDGES TURNING COLOR IN THE BOX BEFORE FIRST USE AND EVIDENCE OF MICROBIAL GROWTH FLOATING AT THE BOTTOM OF FULL, NEVER USED CARTRIDGES. THE CUSTOMER WAS SCREENING THE PRODUCT PRIOR TO USE ON THE ARCHITECT ANALYZER, TO MINIMIZE PREVIOUS ISSUE OF INTER KIT QUALITY CONTROL IMPRECISION ACROSS TWO PACKS OF REAGENT ON BOARD AT THE SAME TIME. THE CUSTOMER PROVIDED CALIBRATION DATA FOR REVIEW, AND THE CUSTOMER LAB INITIATED THEIR OWN MICROBIAL TESTING OF THE FOUR AFFECTED REAGENT PACKS. THE RESULTS OF THE MICROBIAL TESTING DETERMINED NO BACTERIAL ISOLATED, HOWEVER, THE PRESENCE OF A YEAST LIKE ORGANISM, PENICILLIUM SPECIES AND AUREOBASIDUM PULLULANS. 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. 77056HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C16000 ANALYZER, LIST # 3L77-01| ARCHITECT C16000 ANALYZER, LIST # 3L77-01