BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3830645 · Received May 23, 2014

    Report

    Report Number
    1415939-2014-00109
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 1, 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). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION (B)(6).

    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 31203M500 AND ACCEPTANCE CRITERIA WERE MET, INDICATING ACCEPTABLE PRODUCT PERFORMANCE. A REVIEW OF LABELING SHOWS ADEQUATE DISCUSSION OF HOW TO ADDRESS INCONSISTENT RESULTS. A DEFICIENCY WAS NOT IDENTIFIED AS PANEL TESTING SHOWS THAT THE LOT 31203M500 PERFORMED PER SPECIFICATION. THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION. 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 WITH POOR REPRODUCIBILITY ON ONE PATIENT SAMPLE. SID(B)(6) RESULTS = 486.42 / 3.33 / 4.14U/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
    308433 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT LABORATORIES 31203M500

    Patients

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