BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3122823 · Received May 21, 2013

    Report

    Report Number
    1415939-2013-00215
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 23, 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

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ADDITIONAL INFORMATION: ON (B)(4) 2013 THE LOT NUMBER OF 20318M500 WAS PROVIDED. [ORIGINALLY REPORTED: THE LOT NUMBER IS UNKNOWN, BUT THE CUSTOMER STATED IT IS EITHER 17159M500 OR 18071M500.]

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF HISTORICAL DATA, DEVICE HISTORY RECORD REVIEW, A REVIEW OF LABELING, AND ACCURACY TESTING. THE INVESTIGATION INCLUDED REVIEW OF THE SUBMITTED DATA AND PRODUCT HISTORICAL DATA. REVIEW OF THE DATA DID NOT IDENTIFY ANY PRODUCT ISSUE OR ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THIS ISSUE IS LIMITED TO A SINGLE PATIENT. COMPARISON BETWEEN METHODS IS NOT ALLOWED PER PRODUCT LABELING. ACCURACY TESTING WAS COMPLETED USING PANELS AND THE LIKELY CAUSE LOT SHOWS THAT IT CAN ACCURATELY DETECT KNOWN CONCENTRATIONS OF THE ANALYTE AND MET ALL SPECIFICATIONS. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS INVESTIGATION NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). THE LOT NUMBER IS UNKNOWN, BUT THE CUSTOMER STATED IT IS EITHER 17159M500 OR 18071M500.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED ONE PATIENT WITH FALSELY DEPRESSED CA19-9 RESULTS ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) = 12 U/ML, RETEST CONFIRMED 12 U/ML. FROM (B)(6): 7.0, 7.9, 5.3 AND 4.0 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THE PATIENT HAS BEEN TESTED FOR CA19-9 EVERY TWO MONTHS (FOR THE PAST 6 MONTHS) DUE TO A PANCREATIC CANCER DIAGNOSIS. ADDITIONAL RESULTS PROVIDED: RESULTS FROM A REFERENCE LAB (BECKMAN / OTHER METHOD): (B)(6) 2012 REFERENCE LAB APPROXIMATELY 800 U/ML, (B)(6) 2012 REFERENCE LAB 650 U/ML, (B)(6) 2013 REFERENCE LAB 659 U/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223799 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 20318M500

    Patients

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