BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3233856 · Received July 18, 2013

    Report

    Report Number
    1415939-2013-00295
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN 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 28229M500; 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 28229M500, WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CA19-9XR RESULTS FOR ONE PATIENT. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (U/ML): (B)(6) 2013: INITIAL 105, RETEST 104 THESE RESULTS APPEARED ELEVATED COMPARED TO A PREVIOUS SPECIMEN (70) FROM (B)(6) 2013. WHEN THE SPECIMEN FROM (B)(6) 2013 WAS RETESTED ON (B)(6) 2013 A RESULT OF 71 WAS GENERATED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333016 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 28229M500

    Patients

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