BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1231913 · Received November 18, 2008

    Report

    Report Number
    2018433-2008-00218
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS FILED AGAINST CLINICAL CHEMISTRY PHOSPHORUS. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE ARCHITECT ANALYZER IS THE SUSPECT MEDICAL DEVICE. OTHER: ERRATIC UREA AND PHOSPHORUS RESULT. IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS INITIATED TO FURTHER EXAMINE THE CUSTOMER ISSUE. THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT TEXT, THE INSTRUMENT LOGS, THE INSTRUMENT HISTORY, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING. THE REVIEW OF COMPLAINT TEXT INDICATED ON 10/16/2008, THE CUSTOMER OBSERVED ERRATIC UREA AND PHOSPHORUS RESULTS PRODUCED BY THE ARCHITECT C8000 ANALYZER. THE RESULTS OF THE ERRATIC UREA WERE NOT PROVIDED; HOWEVER, THE INITIAL PHOSPHORUS RESULT WAS < 0.7 WITH A REPEAT RESULT OF 4.5. THE INSTRUMENT LOGS PROVIDED BY THE CUSTOMER COULD NOT BE UTILIZED IN DETERMINING A CAUSE, AS THE LOGS DID NOT COVER THE DATE OF OCCURRENCE OF THE ISSUE. IN 2008, THE CUSTOMER REPLACED THE SAMPLE PROBE AND BEGAN RECEIVING ERROR CODE 375: UNABLE TO PROCESS TEST, ASPIRATION OCCURRED, UNABLE TO SUCCESSFULLY CALIBRATE ASSAYS/RUN PATIENT SAMPLES. THE FIELD SERVICE REPRESENTATIVE (FSR) CLEANED AND ALIGNED THE SAMPLE PROBE, PERFORMED VERIFICATIONS AND VERIFIED THE CONTROLS PASSED WITHIN SPECIFICATIONS. THE CUSTOMER INDICATED THEY HAD PLACED A PREVIOUSLY USED SAMPLE PROBE ON THE INSTRUMENT. QUARTERLY MAINTENANCE WAS DUE AND THE SUPPLIES NEEDED FOR THE PROCEDURE WERE NOT ON HAND. THE CUSTOMER ORDERED THE SUPPLIES FOR THE FIELD SERVICE REPRESENTATIVE TO RETURN TO COMPLETE THE MAINTENANCE PROCEDURE. THE FSR INSTALLED A NEW SAMPLE PROBE TO RESOLVE THE ISSUE. ADDITIONALLY, THE FSR REPLACED THE PROBE WASH PUMP DUE TO LEAKING. MAINTENANCE AND DIAGNOSTICS 2132 WAS PERFORMED AND THE WATER LINES WERE FLUSHED THREE TIMES. THE RESULTS OF THE PRECISION RUNS AND QUALITY CONTROL WERE ACCEPTABLE. THE CUSTOMER IS NOW REPEATING PATIENT RESULTS THAT TRIGGER THE DELTA CHECK FAILURE AND THE REPEATED RESULTS MATCH THE INITIAL RESULTS. THE CUSTOMER BELIEVES THE ISSUE HAS BEEN RESOLVED. ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION ABOUT TROUBLESHOOTING FOR ERRATIC RESULTS, ERROR CODE 3375, COMPONENT REPLACEMENT, OPERATIONAL PRECAUTIONS, AND LIMITATIONS. ADDITIONALLY, IN THE CLINICAL CHEMISTRY UREA NITROGEN REAGENT PACKAGE INSERT AND IN THE CLINICAL CHEMISTRY PHOSPHORUS REAGENT PACKAGE INSERT, LITERATURE IS PROVIDED DESCRIBING SUITABLE SPECIMENS, RESULTS, AND LIMITATIONS OF THE PROCEDURE. IF ASSAY RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. NO ADDITIONAL INCIDENTS OF DISCREPANT RESULTS WERE FOUND IN THE COMPLAINT TRACKING SYSTEM FOR THE ARCHITECT. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE CUSTOMER'S ISSUE WAS NOT IDENTIFIED, NOR WAS ANY DEFICIENCY IDENTIFIED FOR THIS COMPLAINT. AFTER THE QUARTERLY MAINTENANCE PROCEDURE AND COMPONENT REPLACEMENT OF SAMPLE PROBE, AND PROBE WASH PUMP AND BY THE FIELD SERVICE REPRESENTATIVE, THE ISSUE HAS NOT BEEN OBSERVED. THIS IS THE FINAL REPORT.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A PHYSICIAN QUESTIONED ONE PATIENT'S PHOSPHORUS ASSAY RESULT OF LESS THAN 0.7 MG/DL GENERATED FROM THE ARCHITECT C8000 ANALYZER. THE SAMPLE WAS RETESTED YIELDING A PHOSPHORUS RESULT OF 4.5 MG/DL. A NEW SAMPLE WAS DRAWN THAT GENERATED A PHOSPHORUS RESULT OF 4.3 MG/DL. THE PHOSPHORUS RESULTS (4.5 MG/DL AND 4.3 MG/DL) ALIGNED WITH THE PATIENT'S PREVIOUS PHOSPHORUS RESULT OF 4.0 MG/DL. 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. 60032HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C8000 ANALYZER