BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1182669 · Received October 3, 2008

    Report

    Report Number
    1628664-2008-00228
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 11, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    TO INVESTIGATE THIS ISSUE, THE INVESTIGATION TEAM REVIEWED THE COMPLAINT TEXT, THE INSTRUMENT LOGS, THE INSTRUMENT HISTORY, AND ARCHITECT SYSTEM LABELING. THE INSTRUMENT LOGS DID NOT COVER THAT DATE OF OCCURRENCE AND COULD NOT BE UTILIZED TO DETERMINE THE CAUSE OF THE COMPLAINT ISSUE. THE REVIEW SHOWED THE ARCHITECT SYSTEM OPERATIONS MANUAL DOES ADDRESS COMPONENT REPLACEMENT PROCEDURES AND ERRATIC RESULTS INCLUDING PROBABLE CAUSES AND CORRECTIVE ACTIONS. ADDITIONALLY THE REVIEW OF THE INSTRUMENT HISTORY SHOWED FOUR ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED INVOLVING ERRATIC RESULTS. SERVICE HISTORY REVIEWS INDICATED THE FIELD SERVICE REPRESENTATIVE VISITED THE CUSTOMER SITE AND RESOLVED ERRATIC RESULTS ISSUES BY REPLACING MULTIPLE COMPONENTS, INCLUDING THE SAMPLE PROBE AND REAGENT CARTRIDGE REPLACEMENT. THE INVESTIGATION TEAM WERE UNABLE TO IDENTIFY THE CAUSE OF THE ISSUE EXPERIENCED AT THE ACCOUNT FACILITY. AFTER THE REPLACEMENT OF THE SAMPLE PROBE, THE INSTRUMENT IS FUNCTIONING AS INTENDED. REFERENCE WHERE IN LABELING THE EVENT IS ADDRESSED: THE ARCHITECT SYSTEM OPERATIONS MANUAL JUNE, 2007): SECTION 7, OPERATIONAL PRECAUTIONS AND 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 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 CUSTOMER ISSUE. IN THE ARCHITECT TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN REAGENT PACKAGE INSERT, LITERATURE IS PROVIDED IN DESCRIBING SUITABLE SPECIMENS, RESULTS, AND LIMITATIONS OF THE PROCEDURE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A PATIENT SAMPLE GENERATED AN ARCHITECT B-HCG RESULT OF 4 IU/L (SAMPLE 1). THE CUSTOMER HAS SET UP THE ANALYZER TO REFLEX TEST ALL THE B-HCG RESULTS BETWEEN 2 IU/L AND 35 IU/L WITH THE ROBOTIC SAMPLE HANDLER (RSH) SET TO AUTOMATICALLY REPOSITION SAMPLES FOR RERUNS. THE REPEAT RESULT FOR THE SAME PATIENT (SAMPLE 1) FOR B-HCG WAS 799 IU/L, WHICH WAS REPORTED AND QUESTIONED BY A PHYSICIAN. THE RETESTING WAS PERFORMED AT THE PHYSICIAN?S REQUEST AND A RESULT OF 3 IU/L WAS REPORTED TO THE PHYSICIAN. FURTHER INVESTIGATION FOUND THAT THE INITIAL SAMPLE (SAMPLE 1) WAS PLACED ONE POSITION DOWN FROM ANOTHER SAMPLE (SAMPLE 2) IN THE CARRIER AND THE CUSTOMER IS CONCERNED THAT THE ANALYZER MAY HAVE ASPIRATED FROM THE INCORRECT SAMPLE. THE OTHER SAMPLE (SAMPLE 2) RESULT WAS 834 IU/L. FURTHER TESTING VERIFIED THAT THE B-HCG RESULTS OF 4 IU/L (SAMPLE 1) AND 834 IU/L (SAMPLE 2) WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI