BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1960004 · Received January 13, 2011

    Report

    Report Number
    1628664-2011-00040
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 20, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CGA
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE ACCOUNT. THE FSR RESOLVED THE ISSUE BY PERFORMING SERVICE ON THE CUVETTE WASHER AND ALIGNING THE MIXERS. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE CLINICAL CHEMISTRY GLUCOSE REAGENT PACKAGE INSERT WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE OF ERRATIC/DISCREPANT RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT C8000 ANALYZER GENERATED DISCREPANT GLUCOSE RESULTS. AN INITIAL RESULT OF 177 MG/DL WAS GENERATED. THE SAMPLE WAS REPEATED WITH RESULTS OF 180 AND 97 MG/DL GENERATED. THE RESULTS WERE NOT REPORTED AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER CGA ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT GLUCOSE RGT LN 3L82 LOT38367UQ03| ARCHITECT GLUCOSE RGT LN 3L82 LOT38367UQ03