BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3111831 · Received May 14, 2013

    Report

    Report Number
    1415939-2013-00211
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 25, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(6).

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, RELEASE TESTING DATA REVIEW, ACCURACY TESTING, AND A REVIEW OF LABELING. A REVIEW OF THE COMPLAINT RECORDS FOR ARCHITECT CA 19-9XR, LIST NUMBER 02K91-25, LOT NUMBER 18069M500 AND LOT NUMBER 20318M500 DID NOT IDENTIFY ANY COMPLAINT TRENDS RELATING TO THIS ISSUE. ACCURACY TESTING WAS COMPLETED USING PANELS WITH A RETAINED KIT OF LOT 18069M500 AND LOT 20318M500 AND SHOWS THAT BOTH LOTS MET ACCEPTANCE CRITERIA. A REVIEW OF PRODUCT LABELING SUFFICIENTLY ADDRESSES THE ISSUE IN THE LIMITATIONS OF THE PROCEDURE SECTION. A REVIEW OF THE RELEASE TESTING FOR THE LOTS WAS PERFORMED AND DID NOT SHOW ANY ISSUE DURING THE MANUFACTURING PROCESS. THE INVESTIGATION SHOWS THAT THERE IS NO PRODUCT DEFICIENCY AND THAT THE ARCHITECT CA 19-9XR REAGENTS ARE PERFORMING AS INTENDED. NO MALFUNCTION WAS IDENTIFIED AS THIS ISSUE IS LIMITED TO A SINGLE PATIENT. BASED ON THE RESULTS OF THIS EVALUATION, THE ARCHITECT CA19-9XR, REAGENT LOT18069M500 AND LOT 20318M500, ARE PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THE ARCHITECT ANALYZER IS GENERATING FALSELY ELEVATED CA19-9 RESULTS ON ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED ON A HEALTHY WOMAN: SID (B)(4) (B)(6) 2013 =240 U/ML; LOT 18069M500, SID (B)(4) (B)(6) 2013 =170.21 U/ML; LOT 18069M500, SID (B)(4) (B)(6) 2013 =396.80 U/ML; LOT 20318M500. THE QUALITY CONTROLS ON ALL THREE ABOVE TEST DATES WERE WITHIN ACCEPTABLE RANGE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213352 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 18069M500

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,| SERIAL (B)(4)| SERIAL (B)(4)| ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,