BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 1882563 · Received October 26, 2010

    Report

    Report Number
    1628664-2010-00392
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER NOTICED SPLASHING ON THE CUVETTES, AND SERVICE WAS REQUESTED. A FIELD SERVICE REPRESENTATIVE (FSR) FOUND THE SAMPLE PROBE WAS OBSTRUCTED AND COVERED WITH SERUM SEPARATOR. AN FSR FOUND THE ALKALINE AND ACID WASH PUMP SMALL SYRINGE TO VALVE TUBING WAS DAMAGED, AND HAD BEEN INSTALLED IN THE WRONG POSITION. THE FSR REPLACED THE TUBING. AN FSR ALSO FOUND 2 O RINGS IN THE REAGENT 1B SYRINGE. THE FSR REPLACED ALL THE SYRINGES WITH NEW O RINGS. THE FSR CHECKED ALL PROBES AND PROBE TUBING, AND PERFORMED A GLUCOSE AND CO2 PRECISION RUN. THE FSR REPLACED THE SAMPLE PROBE, AND THE CUSTOMER VERIFIED CONTROL RESULTS WERE ALL WITHIN SPECIFICATIONS. THE PRODUCT LABELING CONTAINS ADEQUATE INFORMATION ON THE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR DISCREPANT RESULTS. THE PROBABLE CAUSES LISTED INCLUDE SYRINGE SEALS AND/OR O-RINGS HAVE FAILED, PROBE IS OBSTRUCTED, MISALIGNED OR DAMAGED, AND CUVETTE WASHER NOT FUNCTIONING PROPERLY. A REVIEW OF SERVICE HISTORY FOUND NO ADDITIONAL INCIDENTS OF DISCREPANT RESULTS GENERATION ISSUES BY ARCHITECT C16000 (B)(4), SINCE THE FSR SERVICED THE ANALYZER ON (B)(4) 2010. REVIEW OF ADDITIONAL DOCUMENTATION DID NOT IDENTIFY ANY ADVERSE TRENDS DUE TO ISSUES WITH DISCREPANT RESULTS, OR DISCREPANT RESULTS GENERATED DUE TO REAGENT SYRINGE O-RING, SAMPLE PROBE, ALKALINE AND ACID WASH PUMP SMALL SYRINGE TO VALVE TUBING, OR REAGENT SYRINGE SEAL ISSUES. BASED ON THE AVAILABLE INFORMATION AND THIS EVALUATION, NO DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT C16000 PROCESSING MODULE LIST NO. 03L77-01, THE ARCHITECT C8K SAMPLE PROBE LIST NO. 01G48-03, THE REAGENT SYRINGE O-RING LIST NO. 09D53-02, THE ALKALINE AND ACID WASH PUMP SMALL SYRINGE TO VALVE TUBING PART NO. 7-203013-01 THE CC REAGENT SYRINGE SEAL 1 LIST NO. 09D39-02, OR CC REAGENT SYRINGE SEAL 2 LIST NO. 09D40-02 RELATED TO THE ISSUE UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A PATIENT SAMPLE PROCESSED USING THE ARCHITECT C16000 ANALYZER GENERATED A DISCREPANT CO2 RESULT OF 17 MEQ/L COMPARED TO A RESULT OF 32 MEQ/L OBTAINED UPON REPEAT USING AN ALTERNATE ANALYZER. NO ADVERSE OUTCOMES WERE REPORTED RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1