BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 3200805 · Received July 1, 2013

    Report

    Report Number
    1415939-2013-00284
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED AGAINST AN EX-US PRODUCT (02K91-20) THAT HAS A SIMILAR PRODUCT (02K91-27) DISTRIBUTED IN THE US. PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. THE TREND REVIEW IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE ISSUE UNDER INVESTIGATION. THE TICKET SEARCH IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. INITIAL ACCURACY TESTING WAS COMPLETED TO EVALUATE THE ASSAY PERFORMANCE OF LOT 22655M500. FOUR LEVELS OF AN INTERNAL PANEL MADE FROM DEFIBRINATED HUMAN PLASMA WERE TESTED. EACH LEVEL CONTAINS A KNOWN CONCENTRATION OF THE (B)(4). THE RESULTS MET ABBOTT TESTING CRITERIA. AN ABBOTT-LINK ANALYSIS WAS PERFORMED. THE ANALYSIS PERFORMED COMPARED EACH REAGENT LOT PATIENT MEDIAN TO THE AVERAGE MEDIAN PATIENT OF ALL LOTS (WITHIN THE 12 MONTH QUERY, (B)(6) 2012 - (B)(6) 2013) TO DETERMINE IF A CLINICALLY RELEVANT BIAS WAS OBSERVED FOR A PARTICULAR REAGENT LOT. USING THIS DATA, THE AVERAGE PATIENT MEDIAN WAS CALCULATED. THE MEDIAN WAS USED TO DETERMINE THE CONCENTRATION DIFFERENCE OF EACH REAGENT LOT (PATIENT MEDIAN TO THE AVERAGE MEDIAN PATIENT OF ALL LOTS). THE CONCENTRATION DIFFERENCE WAS COMPARED TO THE TOTAL ALLOWABLE BIAS AS DEFINED BY AN INTERNAL REQUIREMENT FOR THE ARCHITECT (B)(4) ASSAY. THE EVALUATED REAGENT LOT DID NOT EXCEED THE INTERNAL REQUIREMENT FOR THE ARCHITECT (B)(4) ASSAY WHICH STATES A MAXIMUM BIAS OF 9.6 U/ML FOR VALUES LESS THAN 37 U/ML IS ALLOWABLE. THE DATA ANALYSIS CONCLUDES THAT ALL REAGENT LOTS READ PATIENT RESULTS CONSISTENTLY. BASED ON THE EVALUATION RESULTS, NO DEFICIENCY OR MALFUNCTION WERE IDENTIFIED TO BE RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER PERFORMED A CORRELATION BETWEEN TWO ARCHITECT CA19-9XR LOTS (22655M500 AND 23263M500) AND NOTICED THAT PATIENT RESULTS ARE HIGHER WITH LOT 22655M500 COMPARED TO THE RESULTS GENERATED WITH LOT 23263M500. THE CUSTOMER ALSO INDICATED THAT PATIENT RESULTS GENERATED WITH LOT 23263M500 ALIGNED WITH THE PATIENTS MONITORING HISTORY. THE CUSTOMER PROVIDED DATA FROM SEVERAL PATIENT SAMPLES. UNIT OF MEASURE IS U/ML. ONE PATIENT SAMPLE (SID (B)(6)) GENERATED A RESULT OF 9.36 WITH LOT 22655M500 AND A RESULT OF 3.43 WITH LOT 23263M500. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298156 ARCHITECT CA 19-9XR NIG ABBOTT LABORATORIES 22655M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2K 03M74-01 SN (B)(4)