BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1893503 · Received November 8, 2010

    Report

    Report Number
    1628664-2010-00405
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REFER TO RESULTS OF INVESTIGATION BELOW. MULTIPLE PARTS REPLACED TO RESOLVE ISSUE. AN EVALUATION WAS PERFORMED BY REVIEWING THE COMPLAINT TEXT, INSTRUMENT LOGS, INSTRUMENT SERVICE HISTORY, AND OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES. A REVIEW OF COMPLAINTS FROM (B)(4) 2010 THROUGH (B)(4) 2010 DID NOT IDENTIFY AN ADVERSE TREND RELATED TO THE CUSTOMER'S ISSUE. ERRATIC RESULT RATES ARE BELOW THE INTERNAL RATE DOCUMENTED AT LAUNCH FOR THE ARCHITECT ANALYZER. BASED UPON THE AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE CUSTOMER'S ISSUE COULD NOT BE IDENTIFIED, HOWEVER SERVICE REPLACED SEVERAL PARTS ON THEIR INSTRUMENT, INCLUDING THE ICT MODULE, SYRINGES, VALVES AND TUBING, MIXER TIP, DRYER TIP, AND R1 AND R2 TUBING AND RESOLVED THE ISSUE. TROUBLESHOOTING AND DIAGNOSTICS IN THE ARCHITECT SYSTEM OPERATIONS MANUAL LISTS SEVERAL PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRATIC ICT RESULTS, INCLUDING SAMPLES, THE ICT MODULE, SYRINGES, CHECK VALVES AND TUBING, REAGENT PROBES, CUVETTE WASHER AND VARIOUS HARDWARE FAILURES. BASED ON THE DATA AVAILABLE AND THE RESULTS OF THE EVALUATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AFTER INSTALLING A NEW ICT MODULE ON THE ARCHITECT C8000 ANALYZER, THERE HAVE BEEN OCCURRENCES OF HIGH CHLORIDE RESULTS. A PATIENT GENERATED AN INITIAL RESULT OF 127 MMOL/L BUT UPON REPEAT, THE RESULT WAS 103 MMOL/L. THE INITIAL RESULT WAS FLAGGED AS IT WAS HIGHER THAN PREVIOUS CHLORIDE RESULTS AND DID NOT ALIGN WITH OTHER RESULTS FROM THE SAME SAMPLE. 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 JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT CHLORIDE| ICT CHLORIDE