BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2040260 · Received April 5, 2011

    Report

    Report Number
    1628664-2011-00140
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED AND REPLACED THE REAGENT 1 PROBE, REAGENT 1 PROBE TUBING, REAGENT SYRINGE, SAMPLE SYRINGE, MIXER, AND THE LID LATCH ON THE REAGENT 1 COVER. THE FSR ALSO ADJUSTED THE REAGENT WASH CUP VOLUME DISPENSE AND CLEANED THE LOW CONCENTRATION WASTE CONTAINER. THE COMPLAINT TEXT INDICATES THAT THE ISSUE IS RESOLVED AND THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. DEVICE EVALUATION INCLUDED A REVIEW OF THE COMPLAINT INFORMATION, INSTRUMENT SERVICE HISTORY, AND A REVIEW OF THE ARCHITECT SYSTEM OPERATIONS MANUAL. A REVIEW OF TRENDING DATA DID NOT IDENTIFY A PRODUCT ISSUE OR ADVERSE TREND ASSOCIATED WITH THIS ISSUE. THE REVIEW DETERMINED THE CURRENT COMBINED ERRATIC RESULT RATE FOR AEROSET, ARCHITECT C4000, C8000, AND C16000 FALLS BELOW THE ESTABLISHED INTERNAL ABERRANT RESULT RATES AT PRODUCT LAUNCH. THE ARCHITECT SYSTEM OPERATIONS MANUAL CONTAINS THE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRATIC RESULTS, POOR PRECISION - PHOTOMETRIC RESULTS (C SYSTEM). NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO THE ISSUE NOR WAS A DEFICIENCY IN THE SYSTEM IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4) (CONCOMITANT MEDICAL PRODUCTS): ARCHITECT CARBON DIOXIDE LIST 3L80-21, LOT 40213UQ09. AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT CARBON DIOXIDE QC AND PATIENT VALUES DECREASED ON THE ARCHITECT C8000 ANALYZER AND THE PHYSICIAN QUESTIONED RESULTS. ONE PATIENT THAT PREVIOUSLY TESTED AT 28 MEQ/L IS NOW TESTING AT 18 MEQ/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CARBON DIOXIDE LIST 3L80-21, LOT 40523UQ10| CARBON DIOXIDE LIST 3L80-21, LOT 40523UQ10