BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIN CHEM ALBUMIN BCG REAGENT

    MDR report key: 1641410 · Received March 26, 2010

    Report

    Report Number
    2018433-2010-00008
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    February 10, 2010
    Report Date
    February 11, 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 DEVICE: ARCHITECT C16000 ANALYZER, LIST # 3L77-01, 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), ADDITIONAL SUSPECT MEDICAL DEVICE LOT # 80051HW00, DEVICE MANUFACTURE DATE: 7/15/09, EXPIRATION: 7/15/11. CONCOMITANT MEDICAL DEVICE: ARCHITECT C16000 ANALZYER, LIST # 3L77-01, 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 (B)(4). 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 (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED CLINICAL CHEMISTRY ALBUMIN BCG REAGENT TO REAGENT IMPRECISION ACROSS TWO REAGENT PACKS ONBOARD THE ARCHITECT C16000 ANALYZER, WHICH WAS CAPTURED IN THE ANALYZER'S (B)(4) DATA. THE CUSTOMER FURTHER OBSERVED REAGENT CARTRIDGES TURNING COLOR IN THE CARTRIDGE BEFORE INITIAL USE AND EVIDENCE OF MICROBIAL GROWTH FLOATING AT THE BOTTOM OF FULL AND NEVER USED CARTRIDGES. PRELIMINARY MICROBIAL CULTURE PERFORMED BY THE CUSTOMER DETERMINED YEAST OR FUNGAL ELEMENTS AND EARLY GROWTH OF PENICILLIUM SP. COLONIES IN 2 OF 4 SPECIFIC CARTRIDGES OF ALBUMIN BCG LOT 77056HW00. 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