BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 2345602 · Received November 22, 2011

    Report

    Report Number
    1628664-2011-00711
    Event Type
    Malfunction
    Date Received
    November 22, 2011
    Date of Event
    November 18, 2011
    Report Date
    November 18, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT; HIGH TEST RESULTS.

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND FOUND THAT THE INSTRUMENT WAS NOT DISPENSING BUFFER PROPERLY AND STATED THAT HE CHANGED THE BUFFER FILTER TO RESOLVE THE ISSUE. A VALVE WAS ALSO REPLACED (NOT SPECIFIED). THE SAMPLE WAS REPEATED ON THIS INSTRUMENT AFTER SERVICE AND GENERATED A TROPONIN -I RESULT WAS 0.028 NG/ML, WHICH WAS IN AGREEMENT WITH RESULTS GENERATED ON ANOTHER ANALYZER. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. FURTHER REVIEW BY ABBOTT ENGINEERING INDICATES THAT THE BUFFER FILTER IS NOT THE LIKELY CAUSE OF THE ISSUE AS STATED IN THE COMPLAINT AS IT FILTERS BUFFER COMING INTO THE WASH BUFFER RESERVOIR, AND DOES NOT IMPEDE THE FLOW FROM THE RESERVOIR TO THE WASH ZONE. AN UNSPECIFIED VALVE WAS ALSO REPLACED; THEREFORE, THE EXACT CAUSE OF THE CUSTOMER'S CURRENT ISSUE CANNOT BE DETERMINED. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL, 201837-108, THE ARCHITECT TROPONIN ASSAY PACKAGE INSERT, 840653/R08, AND THE ARCHITECT I1000SR SERVICE AND SUPPORT MANUAL, 201970-113, ALL CONTAIN INFORMATION IN REGARDS TO THE CUSTOMER'S CURRENT ISSUE. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY OF THE SYSTEM WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE DRAWN IN A GREEN TOP TUBE (HEPARIN) GENERATED AN INITIAL FALSELY ELEVATED ARCHITECT STAT TROPONIN-I ASSAY RESULT OF 0.105 NG/ML. THIS RESULT WAS REPORTED FROM THE LAB. THE CUSTOMER USES A CUT-OFF VALUE OF LESS THAN 0.028 NG/ML. IMMEDIATELY FOLLOWING THIS SAMPLE, THE ARCHITECT I1000SR ANALYZER GENERATED AN ERROR CODE REGARDING A WASH ERROR FOR PROBE #3. THE CUSTOMER THEN RETESTED THIS SAMPLE ON THE OTHER ARCHITECT I1000SR ANALYZER (B)(4) IN THE LAB AND GENERATED RESULTS OF 0.019 AND 0.026 NG/ML. A SERVICE CALL WAS INITIATED AS NUMEROUS ERROR CODES FOR WASH ZONE ASPIRATES HAVE BEEN OCCURRING ON THE SUSPECT ANALYZER. THE FIELD SERVICE ENGINEER NOTICED THAT THE ANALYZER WAS INTERMITTENTLY NOT DISPENSING BUFFER INTO THE REACTION VESSELS THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED AS THE RESULTS FROM THE SECOND ANALYSER WERE SENT AS A CORRECTED REPORT COPY BEFORE ANY PATIENT TREATMENT WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I1000SR ANALYZER MMI ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH STAT TN-I LN:02K41-25 LOT:74219UN11| ARCH STAT TN-I LN: 02K41-25 LOT:74219UN11