BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1122847 · Received August 14, 2008

    Report

    Report Number
    1628664-2008-00194
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ABERRANT RESULTS. AN INVESTIGATION WAS PERFORMED IN RESPONSE TO THE CUSTOMER'S COMPLAINT. THE INVESTIGATION CONSISTED OF A REVIEW OF THE COMPLAINT TEXT, A SERVICE HISTORY REVIEW, AND A REVIEW OF THE ARCHITECT SYSTEM OPERATIONS MANUAL. THE ABBOTT ARCHITECT SYSTEM OPERATIONS MANUAL ((PN 201837-104) JUNE, 2007) PROVIDES THE FOLLOWING INFORMATION RELATED TO ADDRESSING THE CUSTOMER ISSUE: SECTION 7 OPERATIONAL PRECAUTIONS AND LIMITATIONS; 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. THE ARCHITECT SYSTEM OPERATIONS MANUAL LISTS MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRATIC RESULTS. THE PROBABLE CAUSES LISTED INCLUDE SAMPLE CONTAINS FIBRIN CLOTS/PARTICULATE MATTER, SAMPLE NOT COLLECTED/PREPARED PROPERLY AND SAMPLE VOLUME IN CUP/TUBE INADEQUATE. THE MOST PROBABLE CAUSE FOR THE QUESTIONED TOTAL PSA RESULT BEING GENERATED BASED ON THE AVAILABLE INFORMATION WAS SAMPLE INTEGRITY, HOWEVER THIS COULD NOT BE VERIFIED WITH THE AVAILABLE INFORMATION. A REVIEW OF THE INSTRUMENT'S COMPLAINT HISTORY PERFORMED OVER THE TIME PERIOD OF (B)(6) 2008 THROUGH (B)(6) 2008 SHOWED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED CONCERNING ERRATIC RESULTS BEING GENERATED. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THIS IS A 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 I2000SR ANALYZER GENERATED INITIAL TOTAL PSA RESULT OF 0.3 NG/ML ON A PT SAMPLE THAT WAS QUESTIONED BY A PHYSICIAN. THE SAMPLE WAS REPEATED AND GENERATED THE TOTAL PSA RESULT OF 5.3 NG/ML. THERE WAS NO REPORT OF IMPACT TO PT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI ARCHITECT TOTAL PSA REAGENT, LIST# 6C06-32| LOT# UNKNOWN| ARCHITECT TOTAL PSA REAGENT, LIST# 6C06-32