BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1211342 · Received October 28, 2008

    Report

    Report Number
    1628664-2008-00243
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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.

    Additional Manufacturer Narrative · 1

    (B)(4) - ERRATIC POTASSIUM RESULT. INVESTIGATION PLAN/SUMMARY: REVIEW OF THE COMPLAINT TEXT INDICATES THE ARCHITECT C8000 GENERATED AN ERRATIC POTASSIUM RESULT FOR ONE PATIENT ON (B)(6) 2008. THE AUTORETEST FOR POTASSIUM WAS SET AT GREATER THAN 6.5. THE PATIENT SAMPLE GENERATED AN INITIAL POTASSIUM RESULT OF 6.8 AND GENERATED THE RESULT OF 4.5 WHEN IT WAS AUTOMATICALLY REPEATED. THE OPERATOR THEN MANUALLY RERAN THE SAMPLE RESULTING IN 4.5. THE OPERATOR STATED THE QC WAS WITHIN RANGE ON ALL THE RUNS AND THE MAINTENANCE WAS UP TO DATE. QUARTERLY MAINTENANCE WAS DUE ON (B)(6) 2008. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND WAS UNABLE TO VERIFY THE CUSTOMER COMPLAINT. THE FSE CHECKED THE ICT MODULE, CABLING, AND THE SLOPES ON THE INSTRUMENT. ALL OF THE PARAMETERS WERE WITHIN SPECIFICATIONS. THE SAMPLE WAS REDRAWN AND TESTED WITH THE RESULT OF 4.4. THE RESULT OF 4.5 WAS REPORTED OUT OF THE LABORATORY. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE CUSTOMER'S ISSUE WAS NOT IDENTIFIED, NOR WAS ANY DEFICIENCY IDENTIFIED FOR THIS COMPLAINT. A REVIEW OF THE COMPLAINT HISTORY FOR ARCHITECT C SYSTEM SN# (B)(4) OVER THE PERIOD OF TIME OF (B)(6) 2007 THROUGH (B)(6) 2008 WAS PERFORMED. THE REVIEW DID NOT FIND OTHER COMPLAINTS RELATED TO THIS ISSUE. THE EVENT IS ADDRESSED IN THE ARCHITECT SYSTEM OPERATIONS MANUAL ((B)(4) JUNE, 2007): SECTION 7, OPERATIONAL PRECAUTIONS AND LIMITATIONS. LIMITATIONS OF RESULT INTERPRETATION: ASSAY RESULTS MUST BE USED WITH OTHER CLINICAL DATA, FOR EXAMPLE, SYMPTOMS, OTHER TEST RESULTS, PATIENT HISTORY, CLINICAL IMPRESSIONS, INFORMATION AVAILABLE FROM CLINICAL EVALUATION, AND OTHER DIAGNOSTIC PROCEDURES. ALL DATA MUST BE CONSIDERED FOR PATIENT CARE MANAGEMENT. IF ASSAY RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. THE ARCHITECT SYSTEM HAS BEEN VALIDATED FOR ITS INTENDED USE. HOWEVER, ERRORS CAN OCCUR DUE TO POTENTIAL OPERATOR ERRORS AND ARCHITECT SYSTEM TECHNOLOGY LIMITATIONS. SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS, ERRATIC RESULTS, POOR PRECISION - ICT RESULTS (C SYSTEM) LISTS THE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRONEOUS RESULTS. CAUSES INCLUDE ICT ASPIRATION TUBING IS NOT CONNECTED CORRECTLY, HARDWARE FAILURES SUCH AS THE ICT ASPIRATION TUBING OR THE ICT ASPIRATION PUMP, 1 ML SYRINGES IN THE ICT ASPIRATION PUMP OR IN THE ICT REFERENCE SOLUTION PUMP ARE NOT SEATED CORRECTLY. IN THE CLINICAL CHEMISTRY ICT REAGENT PACKAGE INSERT (B)(4), LITERATURE IS PROVIDED IN DESCRIBING SUITABLE SPECIMENS, RESULTS, AND LIMITATIONS OF THE PROCEDURE. THE DEVICE INVOLVED IN THE EVENT WAS EVALUATED. NO FAILURE WAS DETECTED AND THE PRODUCT WAS PERFORMING WITHIN SPECIFICATIONS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A PATIENT SAMPLE GENERATED A DISCREPANT POTASSIUM RESULT WHEN USING THE ARCHITECT C8000 ASSAY. AN INITIAL RESULT OF 6.5 MMOL/L WAS OBTAINED. THE SAMPLE WAS REPEATED TWICE YIELDING 4.5 AND 4.5 MMOL/L RESULTS RESPECTIVELY. A NEW SAMPLE WAS DRAWN, GENERATING A VALUE OF 4.4 MMOL/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED DUE TO THIS ISSUE.

    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 AERO C8K ICT MOD LN:9D28-03 LOT UNK| AERO C8K ICT MOD LN:9D28-03 LOT UNK