BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2963115 · Received February 15, 2013

    Report

    Report Number
    1415939-2013-00050
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, SPECIFICITY TESTING, AND A REVIEW OF LABELING. A REVIEW OF CUSTOMER COMPLAINTS RECEIVED TO-DATE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO DISCREPANT PATIENT RESULTS WITH ARCHITECT CA19-9XR, LIST 2K91-25, LOT 14780M500. ACCURACY TESTING WAS COMPLETED USING AN INTERNAL CA19-9XR PANEL AND RETAINED KITS OF REAGENT LOT 14780M500, WHICH MET ACCEPTANCE CRITERIA. FURTHER INVESTIGATION IS NOT REQUIRED. BASED ON THE RESULTS OF THIS EVALUATION, THE ARCHITECT CA19-9XR ASSAY, LIST 2K91-25, LOT 14780M500, IS PERFORMING AS INTENDED AND NO PRODUCT DEFICIENCY OR MALFUNCTION WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 2K91-25, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-27.

    Description of Event or Problem · 1

    A FALSELY ELEVATED ARCHITECT CA19-9 RESULT OF 70 U/ML WAS GENERATED ON ONE PATIENT SAMPLE DURING A HEALTH SCREENING. UPON EXAMINATION AND REPEAT TESTING OF THE PATIENT THE ARCHITECT CA19-9 RESULT GENERATED LESS THAN 2.00U/ML. THE PATIENT'S CRP RESULT WAS NORMAL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68438 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 14780M500

    Patients

    Seq Age Sex Outcome Treatment
    1 SERIAL # (B)(4)| SERIAL # (B)(4)| ARCHITECT I1000SR ANALYZER, LN 01L86-01| ARCHITECT I1000SR ANALYZER, LN 01L86-01