BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1932122 · Received December 17, 2010

    Report

    Report Number
    1628664-2010-00489
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). A FIELD SERVICE REPRESENTATIVE VISITED THE LAB AND CLEANED THE PROCESS PATH, SHUTTERS, AND OPTICS AND REPLACED THE WASH ZONES INCLUDING THE VALVES ON THE ARCHITECT ANALYZER. ALL FUNCTIONAL TESTS AND CONTROLS PASSED. THE PROLACTIN REAGENT PACKAGE INSERT STATES IF THE PROLACTIN RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. FOR DIAGNOSTIC PURPOSES, RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA; E.G., SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, ETC. THE ISSUE IS ADDRESSED IN PRODUCT LABELING AND LISTS MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS, INCLUDING THE WASH ZONE MANIFOLD LEAKING. A CORRECTIVE ACTION FOR THE WASH ZONE MANIFOLD LEAKING IS TO CHECK FOR SALT CRYSTALS AND/OR LIQUID ON OR AROUND WASH MANIFOLD VALVES AND/OR FITTINGS. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A SAMPLE FROM A PATIENT WAS PROCESSED USING THE ARCHITECT PROLACTIN ASSAY GENERATING A FALSELY LOW RESULT OF <0.6 NG/ML. THE SAMPLE WAS REPEATED TWICE YIELDING RESULTS OF 9.38 AND 9.35 NG/ML. NO ADVERSE OUTCOMES WERE REPORTED RELATED TO THIS ISSUE.

    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 ARC PROLACTIN RGT LN 7K76-25 LOT # 91938JN00| ARC PROLACTIN RGT LN 7K76-25 LOT # 91938JN00