BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 1102011 · Received August 7, 2008

    Report

    Report Number
    1628664-2008-00187
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Report Date
    July 11, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    DHX
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 HISTORY FOR ARCHITECT ISYSTEM SERIAL # I201979 WAS PERFORMED OVER THE TIME PERIOD OF MID 2008 THROUGH LATE 2008. THE REFERENCED QUERY IDENTIFIED MULTIPLE COMPLAINTS HAVE BEEN LOGGED PERTAINING TO ERRATIC CEA RESULTS. IN MID 2008, THE CUSTOMER OBSERVED THAT THE SAMPLE PROBE WAS COATED IN GEL DUE TO THE PROBE GOING TOO LOW INTO THE SAMPLE TUBE. AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED AND REPLACED MULTIPLE PARTS ON THE ANALYZER, INCLUDING THE SAMPLE PROBE. THE CUSTOMER ONCE AGAIN COMPLAINED OF ERRATIC CEA RESULTS. THE FSR SUGGESTED THAT THE CUSTOMER INCREASE THE CENTRIFUGATION TIME IN ORDER TO OPTIMIZE RESULTS. LATER, THE CUSTOMER EXPERIENCED AN ADDITIONAL ERRATIC CEA RESULT AND THE FSR TIGHTENED ALL PUMP BAY CONNECTORS AND FOUND THAT ONE OF THE TRIGGER TUBINGS WAS NOT SEALED PROPERLY. THE FSR REPLACED THE TRIGGER PUMP DUE TO THE SEAL. THE CUSTOMER HAS NOT REPORTED ANY ADDITIONAL COMPLAINTS OF THIS NATURE SINCE THE FSR PERFORMED THE ABOVE TROUBLESHOOTING. THE ARCHITECT SYSTEM OPERATIONS MANUAL (PN 201837-104) SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS - OBSERVED PROBLEMS, ERRATIC ASSAY RESULTS (I SYSTEM) LISTS THE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRATIC ASSAY RESULTS. PROBABLE CAUSES INCLUDE PROBE TIP IS BENT OR DAMAGED, TUBING CONNECTIONS ARE LOOSE, TUBING IS KINKED, SAMPLE WAS NOT COLLECTED AND/OR PREPARED CORRECTLY, SAMPLE VOLUME IN THE SAMPLE CUP OR TUBE WAS INADEQUATE AND SAMPLE CONTAINS FIBRIN CLOTS OR PARTICULATE MATTER. SECTION 5 OPERATING INSTRUCTIONS - PATIENT AND QC RESULTS REVIEW, RERUN, AND RELEASE STATES THAT FLAGS PROVIDE ADDITIONAL INFORMATION ABOUT A RESULT AND INDICATE THAT YOU MAY NEED TO REVIEW THE RESULT. THE DESCRIPTION FOR FLAG '< OR >' IS LISTED AS THE RESULT IS OUTSIDE THE DYNAMIC OR LINEAR RANGE. REVIEW OF THE CEA PACKAGE INSERT (LN 7K68) STATES UNDER SAMPLE COLLECTION AND PREPARATION THAT FOR OPTIMAL RESULTS, SPECIMENS SHOULD BE FREE OF FIBRIN, RED BLOOD CELLS, OR OTHER PARTICULATE MATTER. CENTRIFUGE SERUM AND PLASMA SPECIMENS CONTAINING FIBRIN, RED BLOOD CELLS, OR PARTICULATE MATTER PRIOR TO USE TO ENSURE CONSISTENCY IN THE RESULTS. THE CURRENT COMBINED ERRATIC RESULT RATE FOR ARCHITECT I1000SR, I2000, AND I2000SR FALLS BELOW THE ESTABLISHED INTERNAL ABERRANT RESULT RATES AT PRODUCT LAUNCH. NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO THE ISSUE, AND A REVIEW OF THE INSTRUMENT'S SERVICE HISTORY DID NOT DETECT ANY REPEATS OF THE ISSUE SINCE THE FSR REPLACED THE TRIGGER PUMP AND TIGHTENED ALL PUMP CONNECTIONS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY HAVE HAD OCCURRENCES WHERE PATIENT SAMPLES HAVE GENERATED LOW CEA VALUES ON THE ARCHITECT ANALYZER, BUT WHEN RETESTED, HIGHER EXPECTED VALUES WERE GENERATED. THE CUSTOMER STATED A PATIENT INITIALLY GENERATED A CEA RESULT OF <1 NG/ML, BUT UPON RETEST, THE RESULT WAS 72 NG/ML. THE CUSTOMER IS RETESTING ALL SAMPLES WITH LOW CEA RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER DHX ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI