BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYSTEM SOFTWARE

    MDR report key: 1483631 · Received September 25, 2009

    Report

    Report Number
    1628664-2009-00461
    Event Type
    Malfunction
    Date Received
    September 25, 2009
    Date of Event
    September 11, 2009
    Report Date
    September 11, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Removal / Correction Number
    1628664-9/25/09-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD (B)(4) OTHER, A REVIEW OF THE SOFTWARE CODE, BRAIN STORMING MEETINGS, HUMAN ERROR AND FIVE WHYS ANALYSIS WAS PERFORMED TO DETERMINE ROOT CAUSE OF THE EVENT. THE ROOT CAUSE OF THIS ISSUE WAS IDENTIFIED AS FAILURE TO DOCUMENT THAT ARCHITECT I2000 AND I2000SR INSTRUMENTS WOULD REQUIRE A CHANGE TO THE SLOPE SCORE THRESHOLDS WHEN SOFTWARE V5.00 OR HIGHER IS USED IN CONJUNCTION WITH LLS/PM BOARD FIRMWARE V15 OR 17. THIS ISSUE WAS IDENTIFIED DURING SOFTWARE DEVELOPMENT OF V5.00, BUT NOT CLEARLY DEFINED IN THE SOFTWARE RELEASE ACTION PLAN. IN RESPONSE TO THIS ISSUE TWO MANDATORY TECHNICAL SERVICE BULLETINS WERE ISSUED TO ABBOTT FIELD SERVICE TO CHANGE THE SLOPE SCORE THRESHOLDS ON ALL AFFECTED ANALYZERS. ALL AFFECTED ANALYZERS HAVE BEEN SERVICED. IN ADDITION, ARCHITECT SYSTEM SOFTWARE V7.0 WILL INCLUDE THIS RESOLUTION.

    Additional Manufacturer Narrative · 1

    (B) (4), CONCOMITANT MEDICAL PRODUCTS: ANALYZER LIST NUMBERS 8C89 AND 3M74, PRESSURE MONITORING LIQUID LEVEL SENSE KIT, U10 CHIP AND EJECTORS, PART NUMBER 7-200788-01, AND PRESSURE MONITORING ALGORITHM LIQUID LEVEL SENSE BOARD, PART NUMBER 7-94255-01. INVESTIGATION IN PROCESS, NO METHOD, RESULTS OR CONCLUSION CODE CAN BE CHOSEN AT THIS TIME. 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 ARCHITECT SYSTEM SOFTWARE (B) (4) AND (B) (4) ARE NOT COMPATIBLE WITH THE ENHANCED PRESSURE MONITORING (PM) ALGORITHM LIQUID LEVEL SENSE (LLS) BOARD OR PRESSURE MONITORING LIQUID LEVEL SENSE KIT, U10 CHIP AND EJECTORS. SOFTWARE (B) (4) AND (B) (4) USE INCORRECT SLOPE SCORE THRESHOLDS FOR THE ENHANCED LLS BOARD. THIS CAUSED AN INCREASE IN PRESSURE MONITORING ERRORS FOR THOSE CUSTOMERS WHO HAVE SOFTWARE (B) (4) OR (B) (4) AND THE ENHANCED LLS BOARD BECAUSE THE THRESHOLD RANGE IS TOO NARROW. THE ISSUE MAY OCCUR ON THE I2000 AND I2000SR MODULES ONLY, AND MAY RESULT IN A DELAY OF RESULTS. A PRODUCT CORRECTION HAS BEEN ISSUED AND REPORTED UNDER 21 CFR806 TO THE FDA, (B) (4), UNDER THE REMEDIAL ACTION (B) (4). NO ADVERSE IMPACT TO PATIENT MANAGEMENT HAS BEEN REPORTED RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT SYSTEM SOFTWARE ARCHITECT SYSTEM SOFTWARE JJE ABBOTT MANUFACTURING, INC. VERSIONS 5.00 AND 5.10

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000 AND I2000SR ANALYZERS| ARCHITECT I2000 AND I2000SR ANALYZERS