BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 3299678 · Received August 21, 2013

    Report

    Report Number
    1628664-2013-00215
    Event Type
    Malfunction
    Date Received
    August 21, 2013
    Report Date
    July 29, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    NIG
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ARCHITECT I2000 ANALYZER. THE FSR DESCRIBED THE SHUTTER (PART NUMBER 7-78200-01) AND THE CMIA READER, METAL CASE, TESTED (PART NUMBER 7-201909-01 SP) AS BEING HEAVILY SOILED, AND BOTH PARTS WERE CLEANED TO RESOLVE THE ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION FOR TROUBLESHOOTING FALSELY ELEVATED RESULTS, AND THE ARCHITECT SYSTEM CA 19-9XR PACKAGE INSERT PROVIDES ADEQUATE INFORMATION FOR SAMPLE HANDLING AND EXPECTED ASSAY PERFORMANCE. A REVIEW OF THE ARCHITECT I2000, SERIAL NUMBER (B)(4), SERVICE HISTORY IDENTIFIED NO ADDITIONAL SERVICE OR COMPLAINT TICKETS FOR FALSELY ELEVATED ARCHITECT CA 19-9XR RESULTS. A REVIEW OF QUALITY METRICS IDENTIFIED NO ADVERSE TRENDS FOR THE CMIA READER, METAL CASE, TESTED (PART NUMBER 7-201909-01 SP) AND IDENTIFIED NO TRENDS FOR THE SHUTTER (PART NUMBER 7-78200-01). BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS INVESTIGATION, NO MALFUNCTION OR DEFICIENCY OF THE SHUTTER OR THE CMIA READER, METAL CASE, TESTED COULD BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT FALSELY ELEVATED ARCHITECT CA 19-9XR RESULTS WERE GENERATED FOR PATIENT SAMPLE ID (B)(6). THE CUSTOMER HAS A RETEST RULE FOR ALL SAMPLES WITH INITIAL RESULTS GREATER THAN 37 U/ML. THE FOLLOWING RESULTS WERE GENERATED: 167.952, 44.911, 12.152, 11.501 AND 12.033 U/ML. THERE WERE NO PREVIOUS CA 19-9 VALUES FOR THIS PATIENT. THE SAMPLE WAS RETESTED ON A DIFFERENT ARCHITECT ANALYZER AT THE CUSTOMER SITE AND THE LOWER VALUES WERE CONFIRMED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405353 ARCHITECT I2000 ANALYZER NIG ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LIST 02K91-25, LOT 28294M500| LIST 02K91-25, LOT 28294M500| ARCHITECT CA 19-9XR REAGENT| ARCHITECT CA 19-9XR REAGENT