BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3465089 · Received November 12, 2013

    Report

    Report Number
    1628664-2013-00315
    Event Type
    Malfunction
    Date Received
    November 12, 2013
    Date of Event
    October 21, 2013
    Report Date
    October 21, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) DETERMINED THE VALVE, MANIFOLD KIT (7-77612-02) AS THE CAUSE OF THIS ISSUE. REPLACEMENT OF THE VALVE, MANIFOLD KIT RESOLVED THE ISSUE. THE SERVICE HISTORY DOES NOT INCLUDE FURTHER REPORTS OF DISCREPANT OR QUALITY CONTROL ISSUES RELATED TO THE VALVE, MANIFOLD KIT. NO ADVERSE TRENDS FOR TICKETS WITH REPLACEMENTS OF THE VALVE, MANIFOLD KIT (PART NUMBER 7-77612-02) WERE IDENTIFIED (12/01/2012-11/30/2013 REPORTING PERIOD). THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION OF THE VALVE, MANIFOLD KIT (PART NUMBER 7-77612-02) OCCURRED; THE PART WAS REPLACED DUE TO BEING WORN OUT FROM NORMAL USE. THE ISSUE WAS RESOLVED THROUGH NORMAL TROUBLESHOOTING PROCEDURES. A DEFICIENCY OF THE SYSTEM WAS NOT IDENTIFIED. THE CUSTOMER WAS REFERRED TO THE ARCHITECT SYSTEM OPERATIONS MANUAL WHICH PROVIDES MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS TO ASSIST THE CUSTOMER WITH RESOLVING IMPRECISE QUALITY CONTROL AND DISCREPANT PATIENT RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE (SID (B)(6)) GENERATED A FALSE POSITIVE RESULT OF 0.031 NG/ML AND WHICH WAS REPEATED NEGATIVE AT <0.0010 NG/ML. THE CUSTOMER CUT-OFF FOR POSITIVE RESULTS IS 0.028 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584608 ARCHITECT I2000SR ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT TROPONIN REAGENT 02K41-37, LOT 17195UN13| ARCHITECT TROPONIN REAGENT 02K41-37, LOT 17195UN13