BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3910252 · Received July 2, 2014

    Report

    Report Number
    1415939-2014-00145
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT CA19-9 XR RESULT ON A PATIENT SAMPLE. PATIENT MEAN DATA (COLLECTED FROM ABBOTT LINK) WAS REVIEWED TO DEMONSTRATE ACCEPTABLE ASSAY PERFORMANCE OF LOT 31110M500. THE CONCENTRATION DIFFERENCE BY REAGENT LOT FROM THE AVERAGE PATIENT MEDIAN RANGED FROM -1.464 TO 2.727 U/ML. NONE OF THE REAGENT LOTS EVALUATED EXCEEDED THE INTERNAL REQUIREMENT FOR THE ARCHITECT 19-9 XR ASSAY WHICH STATES A MAXIMUM BIAS OF 9.6 U/ML FOR VALUES < 37 U/ML IS ALLOWABLE. THE ANALYSIS CONCLUDED THAT ALL REAGENT LOTS REVIEWED READ PATIENT RESULTS CONSISTENTLY. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO NON-STATISTICAL TRENDS WERE IDENTIFIED. THE ARCHITECT CA19-9 XR REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT CA19-9 RESULT OF 56.20 U/ML WAS GENERATED. THE SAMPLE WAS REPEATED WITH THE FOLLOWING RESULTS: 9.75, 9.62, 9.55, 9.76 U/ML. THEY REPEATED THE SAMPLE A TOTAL OF 7 TIMES AND ALL RESULTS WERE IN THE NORMAL RANGE. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386585 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT LABORATORIES 31110M500

    Patients

    Seq Age Sex Outcome Treatment
    1 SN (B)(4)| ARCHITECT I2000SR ANALYZER 3M74-02| ARCHITECT I2000SR ANALYZER 3M74-02| SN (B)(4)