BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1406915 · Received June 25, 2009

    Report

    Report Number
    1628664-2009-00241
    Event Type
    Malfunction
    Date Received
    June 25, 2009
    Date of Event
    June 9, 2009
    Report Date
    June 9, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES, CMV IGG REAGENT WAS ENTERED EVALUATION, (OPTICS BOARD, TUBING). THERE WAS NO ADVERSE IMPACT TO PATIENT RESULTS DUE TO THE ERRATIC RESULTS. THE FSR REPLACED AND ADJUSTED MULTIPLE PARTS ON THE I2000SR ANALYZER. THE FSR TIGHTENED LOOSE TUBING, REPLACED THE CMIA OPTICS BOARD, REPLACED WASH ZONE PROBES AND REPLACED THE SAMPLE VALVE SYRINGE TO FINALLY RESOLVE THE ERRATIC RESULTS ISSUE. THE FSR DOCUMENTED THE I2000SR WAS WORKING ACCORDING TO EXPECTED SPECIFICATIONS AFTER SERVICE WAS PERFORMED ON (B)(6) 2009. THE ARCHITECT SYSTEM OPERATIONS MANUAL (96211-110, SECTION 10) WAS FOUND TO CONTAIN ADEQUATE INFORMATION TO RESOLVE ERRATIC RESULTS ISSUES. THE MANUAL LISTS MULTIPLE PROBABLE CAUSES FOR ERRATIC RESULTS INCLUDING LOOSE TUBING CONNECTIONS, CUVETTE WASHER MALFUNCTION, OPTICS MALFUNCTION, AND HARDWARE FAILURE. THE TOXO IGG, (B)(4), CMV IGG, (B)(4) PACKAGE INSERTS WERE REVIEWED AND WERE FOUND TO CONTAIN ADEQUATE INFORMATION ON SPECIMEN COLLECTION AND PREPARATION, CAUTIONS AND LIMITATIONS OF THE PROCEDURE. THE PACKAGE INSERTS NOTE IT IS IMPORTANT TO FOLLOW THE ROUTINE MAINTENANCE PROCEDURES DEFINED IN THE ARCHITECT SYSTEM OPERATIONS MANUAL FOR OPTIMAL ANALYZER PERFORMANCE, AND IF THE ARCHITECT RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. A SERVICE HISTORY REVIEW FOUND NO ADDITIONAL INCIDENTS OF ARCHITECT I2000SR SERIAL NUMBER (B)(4) GENERATING UNRESOLVED ERRATIC RESULTS. THE CURRENT RATE FOR ARCHITECT I2000SR ERRATIC OCCURRENCES/ MILLION TESTS AND COMPLAINTS/ MILLION TESTS ARE WITHIN EXPECTED ACTION LIMITS. THE ERRATIC PATIENT RESULTS WERE MOST PROBABLY CAUSED BY MULTIPLE ISSUES INCLUDING OPTICS MALFUNCTION, WASH ZONE PROBES MALFUNCTION, LOOSE TUBING, AND A MALFUNCTIONING SAMPLE VALVE SYRINGE. THE ACTUAL CAUSE OF THE SUSPECT PATIENT RESULTS COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. BASED ON THE AVAILABLE INFORMATION AND THIS INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I2000SR ANALYZER LIST NO. 03M74-02 RELATED TO THE ISSUE UNDER INVESTIGATION. 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 ACCOUNT STATED THAT THE ARCHITECT I2000SR ANALYZER HAS GENERATED A FALSE REACTIVE TOXOPLASMOSIS IGG RESULT ON A PATIENT SAMPLE. THE INITIAL RESULT WAS 4.0 IU/ML AND THE RETEST RESULT WAS 0 IU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 TOXO- IGG REAGENT LOT UNKNOWN| CMV IGG REAGENT LOT UNKNOWN