BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2604808 · Received June 8, 2012

    Report

    Report Number
    1415939-2012-00310
    Event Type
    Malfunction
    Date Received
    June 8, 2012
    Date of Event
    April 3, 2012
    Report Date
    April 3, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Removal / Correction Number
    1415939-05/30/12-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE ISSUE REVEALED THAT THE CONJUGATE COMPONENT OF THE ARCHITECT CA19-9XR AFFECTED REAGENT LOTS CONTRIBUTED TO ELEVATED CA19-9XR PATIENT SAMPLE CONCENTRATIONS. ALL AFFECTED LOTS SHARE THE SAME CONJUGATE COMPONENT. ABBOTT ISSUED A PRODUCT RECALL FOR THE SIX AFFECTED LOTS (08851M500, 08849M500, 10122M500, 08852M500, 08853M500, 10040M500) OF THE ARCHITECT CA19-9XR REAGENT, INSTRUCTING CUSTOMERS TO DISCONTINUE USE AND DESTROY ANY REMAINING INVENTORY OF THE AFFECTED LOTS.

    Description of Event or Problem · 1

    THE CUSTOMER GENERATED FALSELY ELEVATED ARCHITECT CA19-9XR PATIENT RESULTS WITH RECALLED REAGENT LOT 08851M500 COMPARED TO PREVIOUS REAGENT LOT 08055M500. THE CUSTOMER STATED PATIENT VALUES DOUBLED, HOWEVER, BIORAD TUMOR MARKER QUALITY CONTROLS AND EXTERNAL RCPA QUALITY CONTROLS WERE UNAFFECTED, ALTHOUGH THE CUSTOMER OBSERVED A SHIFT UP IN VALUES WITH OMNI QUALITY CONTROLS. THE FALSELY ELEVATED CA19-9XR RESULTS WERE REPORTED OUT OF THE LAB, HOWEVER, THE LAB ISSUED AMENDED PATIENT REPORTS WHEN SAMPLES WERE RETESTED WITH REAGENT LOT 08055M500. THE CUSTOMER PERFORMED TROUBLESHOOTING OF THE ISSUE BY ASSAY RECALIBRATION, ALTERNATE LOT OF CALIBRATORS, AND TESTING ON A DIFFERENT ARCHITECT WITH NO RESOLUTION. THE CUSTOMER WAS SENT A NEW LOT OF REAGENT WHICH RESOLVED THE ISSUE. THE CUSTOMER PROVIDED AN EXAMPLE OF FALSELY ELEVATED CA19-9XR RESULTS FOR SID (B)(4) GENERATED WITH REAGENT LOT 08055M500 AND RECALLED REAGENT LOT 08851M500 AS FOLLOWS: 5.12 AND 10.49 U/ML, RESPECTIVELY. NONE OF THE FALSELY ELEVATED RESULTS WERE QUESTIONED BY THE MEDICAL PROVIDER, AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 08851M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR, LIST # 3M74-01, SN (B)(4)