BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 1052977 · Received May 27, 2008

    Report

    Report Number
    1628664-2008-00132
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Removal / Correction Number
    1628664-05/23/08-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ABBOTT CUSTOMERS MAY OBSERVE AN ISSUE WITH THE ARCHITECT C8000 SERIES IN WHICH A SOFTWARE DEFECT CAN ALLOW TESTS ORDERED FOR ONE SAMPLE TO BE ASPIRATED FROM A DIFFERENT SAMPLE. THE REPORTED RESULTS ARE ERRONEOUS FOR THE AFFECTED SAMPLE. THE DEFECT WAS IDENTIFIED FOR ARCHITECT C8000, AFFECTING THE INTERACTION OF THE ARCHITECT SYSTEM SOFTWARE WITH THE ARCHITECT C8000 FIRMWARE. THE ISSUE WAS IDENTIFIED WITH ARCHITECT SOFTWARE VERSION 3.10, HOWEVER, THE ISSUE IS PRESENT IN ALL ON-MARKET SOFTWARE VERSIONS. A PRODUCT CORRECTION HAS BEEN ISSUED AND REPORTED FOR ARCHITECT SYSTEM SOFTWARE TO THE FDA DISTRICT IN 2008. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA ARCHITECT SYSTEM SOFTWARE| LIST # 05F48-18