BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 2933539 · Received January 29, 2013

    Report

    Report Number
    1415939-2013-00026
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 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

    THE TREND REVIEW IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. ACCURACY TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE OF LOT 18067M500. THE TESTING MET ACCEPTANCE CRITERIA. THE INVESTIGATION RESULTS SHOW THAT THERE IS NO PRODUCT DEFICIENCY AND THAT THE ARCHITECT CA 19-9XR REAGENTS ARE PERFORMING AS INTENDED. FURTHER INVESTIGATION IS NOT REQUIRED. NO MALFUNCTION WAS IDENTIFIED. THIS ISSUE WAS LIMITED TO A DISCREET PATIENT SAMPLE. RETEST OF THE SAMPLE WITH THE SAME LOT NUMBER GENERATED AN ACCURATE VALUE. ACCURACY TESTING WAS COMPLETED USING PANELS AND THE LIKELY CAUSE LOT SHOWS THAT IT CAN ACCURATELY DETECT KNOWN CONCENTRATIONS OF THE ANALYTE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE SAMPLE IDENTIFICATION NUMBER IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-27.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE PATIENT SAMPLE GENERATED A FALSELY ELEVATED ARCHITECT CA19-9 ASSAY RESULT OF 165 U/ML. THE CUSTOMER PERFORMED MULTIPLE RUNS ON THE SAMPLE WITH THE SAME REAGENT LOT, GENERATING THE FOLLOWING RESULTS: REPEAT RESULTS (U/ML) LESS THAN 22.833. CUSTOMER REPORTED FROM THE LAB THE VALUE OF LESS THAN 2. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38970 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 18067M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR, LN 03M74-01| SN (B)(4)| SN (B)(4)| ARCHITECT I2000SR, LN 03M74-01