BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 1241423 · Received November 25, 2008

    Report

    Report Number
    1415939-2008-00515
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    DHA
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUSPECT MEDICAL DEVICE HAS BEEN UPDATED TO REFLECT A CHANGE: THE INITIAL MDR WAS FILED AGAINST ARCHITECT B-HCG, LIST NUMBER 6C21-27, (B)(4). UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE ARCHITECT I2000 WAS THE SUSPECT MEDICAL DEVICE. IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS INITIATED TO FURTHER EXAMINE THE CUSTOMER ISSUE. THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. REVIEW OF THE COMPLAINT TEXT INDICATES THE CUSTOMER WAS HAVING ISSUES REPRODUCING TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (B-HCG). PER CUSTOMER SUPPORT TROUBLESHOOTING RECOMMENDATIONS, THE OPERATOR CHANGED THE SAMPLE PROBE AND WASH ZONE MANIFOLD. THE ISSUE WAS RESOLVED AFTER THE TROUBLESHOOTING WAS PERFORMED AND THE INSTRUMENT WAS RETURNED TO SPECIFICATIONS. NO ISSUES OF ERRATIC B-HCG HAVE BEEN OBSERVED SINCE THE REPLACEMENT OF THE SAMPLE PROBE AND WASH ZONE MANIFOLD. A REVIEW OF THE COMPLAINT HISTORY FOR ARCHITECT ISYSTEM (B)(4) OVER THE PERIOD OF TIME OF (B)(6) 2007 THROUGH (B)(6) 2009 WAS PERFORMED. THE REVIEW DID FIND SIX OTHER COMPLAINTS RELATED TO THIS ISSUE. THE COMPLAINT ISSUES WERE RESOLVED BY COMPONENT REPLACEMENT, REAGENT REPLACEMENT, AND SAMPLE HANDLING CORRECTIONS. NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL: SECTION 7, OPERATIONAL PRECAUTIONS AND LIMITATIONS, LIMITATIONS OF RESULT INTERPRETATION STATES: 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. SERVICE AND MAINTENANCE: COMPONENT REPLACEMENT PROVIDES THOROUGH INSTRUCTIONS ON THE PROCEDURE TO REMOVE, REPLACE, AND VERIFY A SAMPLE PROBE. TROUBLESHOOTING AND DIAGNOSTICS UNDER OBSERVED PROBLEMS LIST MULTIPLE PROBABLE CAUSES AND RESOLUTIONS RELATED TO THE CUSTOMER'S ISSUE. BASED UPON THE INVESTIGATION, A MALFUNCTION OF THE ARCHITECT I2000 ANALYZER, (B)(4) OCCURRED AND WAS MOST LIKELY DUE TO AN OBSTRUCTED SAMPLE PROBE AND LEAKING WAS ZONE MANIFOLD. AFTER REPLACEMENT OF THE SAMPLE PROBE AND WAS ZONE MANIFOLD, THE ARCHITECT I2000 ANALYZER, LIST NUMBER 3M74-01, (B)(4) WAS PERFORMING WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I2000 SYSTEM. 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 THE ARCHITECT TOTAL B-HCG ASSAY GENERATED DISCREPANT RESULT ON ONE PATIENT SAMPLE. SEE DATA BELOW. INITIAL TOTAL B-HCG RESULT = 50. REPEAT TOTAL B-HCG RESULT = NEGATIVE. REFERENCE LABORATORY, TOTAL B-HCG RESULT = NEGATIVE. THERE IS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT BHCG LN 6C21-27| ARCHITECT I2K ANALYZER, LN 3M74