BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1132785 · Received August 19, 2008

    Report

    Report Number
    1628664-2008-00201
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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

    A REVIEW OF THE COMPLAINT TEXT INDICATES THE ARCHITECT C8000 GENERATED AN ERRATIC CREATININE RESULTS FOR ONE PATIENT IN 2008. THE HISTORICAL DATA OF THIS PATIENT WAS AN AVERAGE OF 8 FOR CREATININE. THE PATIENT SAMPLE GENERATED AN INITIAL CREATININE RESULT OF 5.3 AND GENERATED THE RESULTS OF 8.9 AND 9.2, RESPECTIVELY, WHEN IT WAS REPEATED. A REPRODUCIBILITY TEST WAS PERFORMED AND THE CONTROLS PASSED THE SPECIFICATIONS. THE OPERATOR STATED THE QUARTERLY MAINTENANCE WAS COMPLETED IN THE MONTH PRIOR. THE OPERATOR CHECKED THE R1 PROBE, R2 PROBE, WASH UNIT PROBE, AND THE AGITATORS ON THE INSTRUMENT. THE SAMPLE PROBE WAS THEN REPLACED. ONCE THE SAMPLE PROBE WAS PLACED ONTO THE INSTRUMENT, ERROR CODE 3375 (UNABLE TO PROCESS TEST, ASPIRATION ERROR OCCURRED) WAS GENERATED. THE OPERATOR THEN ADJUSTED THE PLACEMENT AND ROUTING OF THE SAMPLE PROBE TO REALIZE THE CALIBRATION TOOL WAS NOT REMOVED FROM THE CAROUSEL FROM THE MAINTENANCE PROCEDURE. THE CALIBRATIONS PASSED AND THE OPERATOR HAS NOT OBSERVED ANY OTHER ISSUES WITH ERRATIC RESULTS SINCE THE REPLACEMENT OF THE SAMPLE PROBE. IN THE ARCHITECT SYSTEM OPERATIONS MANUAL ((PN 201837-104) JUNE, 2007): SECTION 7, OPERATIONAL PRECAUTIONS AND LIMITATIONS, IT STATESLIMITATIONS OF RESULT INTERPRETATIONASSAY 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.IN SECTION 9: SERVICE AND MAINTENANCE: COMPONENT REPLACEMENT PROVIDES THOROUGH INSTRUCTIONS ON THE PROCEDURE TO REMOVE, REPLACE, AND VERIFY A SAMPLE PROBE. IN SECTION 10: TROUBLESHOOTING AND DIAGNOSTICS UNDER OBSERVED PROBLEMS LIST MULTIPLE PROBABLE CAUSES AND RESOLUTIONS RELATED TO THE CUSTOMERS ISSUE.IN THE CLINICAL CHEMISTRY CREATININE REAGENT PACKAGE INSERT (30-3916/R7), LITERATURE IS PROVIDED IN DESCRIBING SUITABLE SPECIMENS, RESULTS, AND LIMITATIONS OF THE PROCEDURE.THE ISSUE WAS MOST LIKELY CAUSED BY AN OBSTRUCTED SAMPLE PROBE. AFTER THE REPLACEMENT OF THE SAMPLE PROBE, THE INSTRUMENT WAS RUNNING WITHIN SPECIFICATIONS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT C8000 ANALYZER IS GENERATING ERRATIC CREATININE RESULTS FOR ONE PATIENT. THE INITIAL RESULT WAS 5.3, THE SAMPLE WAS THEN REPEATED TWICE AND THE RESULTS WERE 5.9 AND 9.2. THE PATIENT WAS KNOWN TO HAVE A CREATININE RESULT OF 8.0. (UNITS OF MEASUREMENT WAS NOT PROVIDED). THE QC WAS WITHIN RANGE. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI