BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3792058 · Received May 6, 2014

    Report

    Report Number
    1415939-2014-00101
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 13, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A REVIEW FOR SIMILAR COMPLAINTS, ACCURACY TESTING, AND A REVIEW OF LABELING. THE CUSTOMER OBSERVED FALSELY ELEVATED CA19-9 RESULTS. A REVIEW OF COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR FALSELY ELEVATED RESULTS. ACCURACY TESTING WAS PERFORMED WITH A RETAINED KIT OF LOT 31111M500 AND IT FAILED FOR PANEL 1 OUT OF SPECIFICATION. RETEST PER PROCEDURE ALSO FAILED DUE TO PANEL 1 OUT OF SPECIFICATION. ALTHOUGH THE FIELD DATA SHOWED THE ASSAY IS PERFORMING AS INTENDED, THE ACCURACY TESTING FOR LOT 31111M500 FAILED WHICH WILL BE FURTHER EVALUATED. A DEFICIENCY WAS NOT IDENTIFIED AS THE PATIENT MEAN DATA REVIEW SHOWS THAT LOT 31111M500 PERFORMED PER SPECIFICATION. THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION. THE ISSUE IS FOR ONE PATIENT SAMPLE AND THE INITIAL RESULT WAS FALSELY ELEVATED AND RETEST RESULTS WERE AS EXPECTED. THE COMPLAINT TEXT INDICATES THAT THE INITIAL RESULT COULD HAVE BEEN CAUSED BY INCOMPLETE BLOOD COAGULATION WHICH IS ADDRESSED IN LABELING UNDER SAMPLE HANDLING. NO ADDITIONAL ISSUES WERE IDENTIFIED; NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY ELEVATED CA19-9 RESULTS ON ONE PATIENT SAMPLE. THE RESULTS PROVIDED WERE: INITIAL = 353.21 / RETESTED WITHOUT RE-CENTRIFUGING = 5.18 / 7.40 / 5.33U/ML. PREVIOUS RESULT FROM 3 MONTHS AGO = 3.41U/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270969 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT LABORATORIES 31111M500

    Patients

    Seq Age Sex Outcome Treatment
    1 SERIAL # (B)(4)| SERIAL # (B)(4)| ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,| ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,