BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3063587 · Received April 17, 2013

    Report

    Report Number
    1415939-2013-00175
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    April 7, 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

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. AN ACCURACY TESTING PROTOCOL WAS EXECUTED USING LOT 19166M500. TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT CA19-9XR REAGENT LIST NUMBER 02K91, LOT NUMBER 19166M500, WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED CA19-9 RESULT WHILE USING THE ARCHITECT CA19-9XR ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA (U/ML): INITIAL: 490.6, RETEST RESULTS 5.8, 5.2 TESTING WAS COMPLETED AT A REFERENCE LAB AND ALIGNED WITH THE RETEST RESULTS. THE METHOD USED WAS NOT SPECIFIED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165034 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 19166M500

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 08C89-01, SN (B)(4)| ARCHITECT I2000 ANALYZER| LN 08C89-01, SN (B)(4)| ARCHITECT I2000 ANALYZER