BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3000257 · Received March 12, 2013

    Report

    Report Number
    1415939-2013-00142
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    January 25, 2013
    Report Date
    March 5, 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

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. ACCURACY TESTING WAS COMPLETED USING PANELS AND THE LIKELY CAUSE LOT SHOWED THAT IT CAN ACCURATELY DETECT KNOWN CONCENTRATIONS OF THE ASSAY. THE TREND REVIEW IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. BASED ON THE EVALUATION RESULTS, NO PRODUCT DEFICIENCY OR MALFUNCTION WERE IDENTIFIED TO BE RELATED TO THIS ISSUE AS THE INCIDENT WAS LIMITED TO A SINGLE PATIENT SAMPLE. TESTING OF A NEW SAMPLE WITH THE SAME LOT GENERATED A LOWER RESULT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AGAINST AN EX-US PRODUCT (2K91-25) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US (2K91-27). (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE GENERATED A HIGHER THAN EXPECTED RESULT FOR THE ARCHITECT CA19-9XR ASSAY. THE PATIENT WAS MONITORED WITH RESULTS AS FOLLOWS:A RESULT OF 9.2 U/ML WAS OBTAINED BACK IN (B)(6) 2012. RESULTS OF 45.5 AND 43.9 U/ML WERE GENERATED IN (B)(6) 2013 AND A RESULT OF 8.1 U/ML WAS GENERATED IN (B)(6) 2013. THE CUSTOMER SUSPECTED THE RESULTS GENERATED IN (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103223 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 18069M500

    Patients

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