BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3358386 · Received September 19, 2013

    Report

    Report Number
    1415939-2013-00343
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    July 8, 2013
    Report Date
    August 30, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION 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 28177M500. 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 28177M500, WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ON 12/19/2013 THE SUSPECT DEVICE LOT NUMBER WAS PROVIDED: 28177M500.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED CA19-9 RESULTS FOR ONE FEMALE (B)(6) PATIENT WHILE USING THE ARCHITECT CA19-9XR ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: (B)(6) 2013: 33 U/ML. (B)(6) 2013: 65 U/ML. TESTING WAS COMPLETED ON ANOTHER ARCHITECT ANALYZER FOR CONFIRMATION (DATE NOT PROVIDED): 64.7 NG/ML IT WAS INDICATED THAT THE PATIENT WAS TESTED AT ANOTHER LAB AND THE RESULTS WERE NOT ELEVATED (ROCHE METHOD). ADDITIONALLY, THE PATIENT HAS BEEN TESTED BY 2 OTHER LABORATORIES AND GENERATED NON-DISCREPANT RESULTS (METHODS NOT PROVIDED). THE PATIENT HISTORY HAD INDICATED THAT SHE HAD HER GALL BLADDER OUT IN (B)(6) 2012 AND WAS TAKING AMLODIPINE FOR HYPERTENSION. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473739 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 28177M500

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR ARCHITECT I2000SR ANALYZER| LN 03M74-01, SN(B)(4).| LN 03M74-01, SN (B)(4).| ARCHITECT I2000SR ANALYZER| LN 03M74-01, SN (B)(4).| ARCHITECT I2000SR ANALYZER