BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 5695853 · Received June 2, 2016

    Report

    Report Number
    1415939-2016-00061
    Event Type
    Injury
    Date Received
    June 2, 2016
    Report Date
    June 10, 2016
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND ACCURACY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. AN INTERNAL PANEL WAS TESTED WITH RETAINED KITS OF THE LIKELY CAUSE REAGENT LOT AND ACCURACY TESTING MET ALL SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, THE ASSAY PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED CA 19-9 RESULTS GENERATED WITH THE ARCHITECT CA 19-9XR REAGENTS. THE FOLLOWING DATA WAS PROVIDED (U/ML). TESTED IN (B)(6) 2016: 548. PREVIOUS RESULTS PROVIDED WERE 122 ((B)(6) 2016), 85, ((B)(6) 2016), 98 ((B)(6) 2016), AND 77, (B)(6) 2016. THE PATIENT WAS DIAGNOSED WITH DIABETES , HYPERLIPIDEMIA, AND HYPERTENSION. DIAGNOSTIC TESTS INCLUDING CT, ECHO, MRI, AND PET WERE COMPLETED AFTER THE ELEVATED (B)(6) 2016 TEST AND SHOWED NO TUMOR. IV CONTRAST (18F-FDG (THE FLUORO-DEOXY-GLUCOSE) WAS ADMINISTERED FOR THE POSITRON EMISSION TOMOGRAPHY (PET) SCAN. THE PATIENT WAS NOT DIAGNOSED WITH AND WAS NOT BEING MONITORED FOR PANCREATIC CANCER. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED AND NO FURTHER DETAILS ARE KNOWN. THE EVENT CAUSED UNNECESSARY ADMINISTRATION OF IV CONTRAST FOR A PET SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349355 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT LABORATORIES 50376M500

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other