BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 6084210 · Received November 7, 2016

    Report

    Report Number
    1415939-2016-00104
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Report Date
    December 22, 2016
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND ACCURACY TESTING. HISTORICAL PERFORMANCE OF THE REAGENT LOT WAS EVALUATED USING WORLD WIDE DATA FROM ABBOTT LINK. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR THIS LOT IS WITHIN THE ESTABLISHED CONTROL LIMITS AND NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. 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 CA19-9 RESULTS ON THE ARCHITECT I2000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED SID (B)(6): INITIAL 1023, REPEAT 843, 840, 674, 824, 425, 643, 714, >1200, 1095, 1161, >1200, 500, >1200, 909 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732255 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT LABORATORIES 64006M800

    Patients

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