BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 15-3

    MDR report key: 1183183 · Received October 3, 2008

    Report

    Report Number
    1415939-2008-00504
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MOI
    PMA / PMN Number
    K042732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). NO RETURN MATERIAL WAS RECEIVED FROM THE CUSTOMER. TRACKING AND TRENDING REVIEW: AS PART OF THE INVESTIGATION A REVIEW OF TRACKING AND TRENDING WAS PERFORMED. THIS REVIEW DID NOT IDENTIFY ANY TRENDS RELATED TO THE ISSUE UNDER INVESTIGATION. NO ISSUES WERE IDENTIFIED RELATED TO THE COMPLAINT THAT WOULD INDICATE THAT THERE IS A PRODUCT DEFICIENCY. LABELING REVIEW: SECTION 10 OF THE ARCHITECT SYSTEM OPERATIONS MANUAL LISTS POSSIBLE CAUSES AND CORRECTIVE ACTIONS FOR THE ISSUE OBSERVED BY THE CUSTOMER. A FEW POSSIBLE REASONS FOR ERRATIC/DISCREPANT RESULTS ARE: REAGENTS STORED INCORRECTLY, BUBBLES OR FOAM ON THE SURFACE OF THE REAGENT, SAMPLE NOT COLLECTED AND/OR PREPARED CORRECTLY, AND/OR SAMPLE CONTAINS FIBRIN CLOTS OR PARTICULATE MATTER. ADDITIONALLY, THE ARCHITECT CA 15-3 PACKAGE INSERT (B)(4) NOTES TO ENSURE COMPLETE CLOT FORMATION IN SERUM SPECIMENS HAS TAKEN PLACE PRIOR TO CENTRIFUGATION. IF THE SPECIMEN IS CENTRIFUGED BEFORE A COMPLETE CLOT FORMS, THE PRESENCE OF FIBRIN MAY CAUSE ERRONEOUS RESULTS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY WERE HAVING REPRODUCIBILITY PROBLEMS WITH ARCHITECT CA15-3 REAGENT LIST 2K44-25. AN INITIAL RESULT OF 9 U/ML WAS GENERATED. THE SAMPLE WAS REPEATED AND RESULTS OF 58 U/ML AND 60 U/ML WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 15-3 FOR THE DETERMINATION OF DF3 DEFINED ANTIGEN IN HUMAN SERUM OR PLASMA MOI ABBOTT LABORATORIES NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI ARCHITECT ANALYZER 3M74-01, (B)(4).| ARCHITECT ANALYZER 3M74-01, (B)(4).