BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3881002 · Received June 18, 2014

    Report

    Report Number
    1628664-2014-00118
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT TEXT INDICATES SEVERAL FALSELY DECREASED TSH RESULTS WERE GENERATED ON ARCHITECT I2000SR ((B)(4)). ON THE SAME DATE, A SERVICE TICKET WAS OPENED FOR A REPORTED LEAK UNDER THE INSTRUMENT. THE ABBOTT FIELD SERVICE REPRESENTATIVE DETERMINED THE LEAK WAS CAUSED BY THE VALVE MANIFOLD KIT (PART NUMBER 7-77612-03) ON WASH ZONE 1 AND WASH ZONE 2. THE COMPLAINT TEXT STATES THAT IMPROPER RINSING OF THE NEEDLES CAUSED THE PROBLEM WITH THE RESULTS. REPLACEMENT OF VALVE MANIFOLD KIT ON WASH ZONE 1 AND 2 WAS CONSIDERED TO HAVE RESOLVED THE RESULTS ISSUE AND THE LEAKING THROUGH NORMAL TROUBLESHOOTING PROCEDURES. THE VALVE MANIFOLD KIT WAS NOT AVAILABLE FOR RETURN. THE ARCHITECT TSH PACKAGE INSERT PROVIDES ADEQUATE INFORMATION RELATED TO HANDLING SPECIMENS AND CONSUMABLES, REQUIRED MAINTENANCE, AND TROUBLESHOOTING THE CUSTOMER'S REPORTED ISSUE. THE SUBSEQUENT SERVICE HISTORY DOES NOT INCLUDE ANY FURTHER REPORTS OF ERRATIC OR DISCREPANT PATIENT RESULTS AFTER THE VALVE MANIFOLD KITS WERE REPLACED. HISTORICAL COMPLAINT TRACKING AND TRENDING REVIEW FOR THE VALVE MANIFOLD KIT DID NOT IDENTIFY ANY ADVERSE TRENDS. THE COMPLAINT INFORMATION REASONABLY SUGGESTS A MALFUNCTION OF THE VALVE, MANIFOLD KIT OCCURRED. NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT FALSELY DECREASED TSH RESULTS WERE GENERATED FOR TEN PATIENT SAMPLES TESTED ON THE ARCHITECT I2000SR ANALYZER. ONE EXAMPLE WAS PROVIDED. AN INITIAL RESULT OF 0.03 MIU/ML RETESTED AT 1.50 MIU/ML. THE CUSTOMER'S NORMAL RANGE IS 0.35 - 4.94 MIU/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357129 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT NUMBER UNKNOWN| ARCHITECT TSH REAGENT LIST 07K62-25| ARCHITECT TSH REAGENT LIST 07K62-25| LOT NUMBER UNKNOWN