BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3021649 · Received March 26, 2013

    Report

    Report Number
    1415939-2013-00162
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT TREND REVIEW IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. COMPLAINT REVIEW FOR REAGENT LOT 18069M500 IDENTIFIED ATYPICAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. ACCURACY TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE OF LOT 18069M500. THE TESTING MET ACCEPTANCE CRITERIA. INVESTIGATION RESULTS SHOW THAT THERE IS NO PRODUCT DEFICIENCY AND THAT THE ARCHITECT CA 19-9XR REAGENTS ARE PERFORMING AS INTENDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT CA 19-9XR RESULT OF 77.08 U/ML WAS GENERATED ON (B)(6) 2013 FOR A PATIENT THAT TESTED AT <2.0 U/ML ON (B)(6) 2013. THE ELEVATED SAMPLE RETESTED AT 4.09 AND 5.80 U/ML ON (B)(6) 2013. THE CA 9-9XR REAGENT LOT USED FOR TESTING ON (B)(6), 2013 WAS LOT 18069M500. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124406 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 18069M500

    Patients

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