BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3950851 · Received July 22, 2014

    Report

    Report Number
    1415939-2014-00164
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    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

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT CA 19-9XR RESULT ON A PATIENT THAT HAD PREVIOUSLY BEEN LOWER. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 33394M500. ACCEPTANCE CRITERIA WERE MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. THE ARCHITECT CA 19-9XR REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT CA 19-9 RESULT WAS GENERATED ON A PATIENT THAT PREVIOUSLY HAD BEEN LOWER. ON (B)(6) 2014 AN INITIAL RESULT OF 66.92 U/ML WAS GENERATED. THE SAMPLE WAS REPEATED WITH RESULTS OF 3.4 AND 5.06 U/ML. IN (B)(6) THE PATIENT HAD A RESULT OF 6 U/ML. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428737 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT LABORATORIES 33394M500

    Patients

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