BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 19-9XR

    MDR report key: 8376688 · Received February 27, 2019

    Report

    Report Number
    3002809144-2019-00077
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Report Date
    April 9, 2019
    Manufacturer
    ABBOTT GERMANY
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER FOR THE LIKELY CAUSE (LIST 02K91-32) WAS UPDATED FROM UNKNOWN TO 91014M800. AN INVESTIGATION WAS PERFORMED FOR THE CUSTOMER ISSUE AND INCLUDED A REVIEW OF COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF HISTORICAL PERFORMANCE, TRACKING AND TRENDING, AND PRODUCT LABELING. TICKET REVIEW FOR THE LIKELY CAUSE LOT NUMBER 91014M800 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THIS ISSUE. A REVIEW OF WORLD WIDE DATA INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 91014M800 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR LOT 91014M800. TRACKING AND TRENDING REVIEW DID NOT IDENTIFY ANY ADVERSE TRENDS OR NON-STATISTICAL TRENDS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT CA 19-9 RESULTS WHEN PROCESSING ON THE ARCHITECT I2000SR. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2018: 40 U/ML, ON (B)(6) 2018: 50 U/ML, ON (B)(6) 2019: 83.24 U/ML. THE CUSTOMER ALSO REPORTED A RETEST FROM (B)(6) 2019 TO BE NORMAL; HOWEVER, NO SPECIFIC VALUE WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166439 ARCHITECT CA 19-9XR CA 19-9 NIG ABBOTT GERMANY 91014M800

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER, LN 03M74-95| ARCHITECT I2000SR ANALYZER, LN 03M74-95| SERIAL (B)(4)| SERIAL (B)(4)| ARCHITECT I2000SR ANALYZER, LN 03M74-95| SERIAL (B)(4)