BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3132556 · Received May 29, 2013

    Report

    Report Number
    1415939-2013-00222
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 9, 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

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED PATIENT RESULTS FOR THREE PATIENTS. THE TREND REVIEW IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. ACCURACY TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE OF LOT 18069M500. THE TESTING MET ACCEPTANCE CRITERIA. THE INVESTIGATION RESULTS SHOW THAT THERE IS NO PRODUCT DEFICIENCY AND THAT THE ARCHITECT CA 19-9XR REAGENTS ARE PERFORMING AS INTENDED. A MALFUNCTION WAS NOT IDENTIFIED. THIS ISSUE IS LIMITED TO A DISCREET NUMBER OF PATIENTS. IN ADDITION THE CUSTOMER DID NOT RUN ALL THREE LEVELS OF CONTROLS EVERYDAY AS SPECIFIED IN THE PRODUCT LABELING, IN ADDITION WHEN THE LOW CONTROL WAS RUN IT WAS OUT OF RANGE. ACCURACY TESTING WAS COMPLETED USING PANELS AND THE LIKELY CAUSE LOT SHOWS THAT IT CAN ACCURATELY DETECT KNOWN CONCENTRATIONS OF THE ASSAY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THREE PATIENT SAMPLES GENERATED HIGHER THAN EXPECTED RESULTS FOR THE ARCHITECT CA19-9XR ASSAY. ONE PATIENT SAMPLE (SID (B)(4)) GENERATED THE FOLLOWING RESULTS (UNIT OF MEASURE WAS NOT PROVIDED): 48.91 63.54 44.30 31.73 28.44. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234501 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 18069M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR 01L86-01 SN (B)(4)