BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA 125 II REAGENT

    MDR report key: 3833297 · Received May 27, 2014

    Report

    Report Number
    1415939-2014-00110
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTION: SUSPECT MEDICAL DEVICE; CATALOG # FROM 02K45-28 TO 02K45-20. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A REVIEW OF COMPLAINT HISTORY, ACCURACY TESTING, AND A REVIEW OF LABELING. THE CUSTOMER REPORTED FALSELY ELEVATED CA125 RESULTS. A REVIEW OF COMPLAINTS AND A SEARCH BY LOT NUMBER 29103M500 DID NOT IDENTIFY ANY COMPLAINTS RELATED TO FALSELY ELEVATED PATIENT RESULTS. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 29130M500 AND ALL ACCEPTANCE CRITERIA WERE MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. A DEFICIENCY WAS NOT IDENTIFIED AS PANEL TESTING SHOWS THAT LOT 29103M500 PERFORMED PER SPECIFICATIONS. THERE IS A MALFUNCTION SINCE DIFFERENT SAMPLES OF THE SAME PATIENT WERE TESTED NUMEROUS TIMES WITH LOT 29103M500 AND PRODUCED FALSELY ELEVATED RESULTS AND RETEST OF ONE THE SAMPLES PRODUCED NEGATIVE RESULTS WITH OTHER REAGENT LOTS. A REVIEW OF LABELING SHOWED ADEQUATE DISCUSSION REGARDING FALSELY ELEVATED CA125 PATIENT RESULTS. NO ADDITIONAL ISSUES WERE IDENTIFIED; NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY ELEVATED CA125 RESULTS ON ONE FEMALE PATIENT. THE REPRODUCTION CENTER IN THE COURSE OF PERFORMING ROUTINE TESTING FOR A IN-VITRO FERTILIZATION (IVF) PROCEDURE, GENERATED THE FOLLOWING CA125 RESULTS: (B)(6) 2014 = 157 U/ML; (B)(6) 2014 = 139.10U/ML; (B)(6) 2014 = 140.40U/ML; (B)(6) 2014 = 141.60U/ML. THE PATIENT WAS REFERRED TO THE HOSPITAL TESTING LAB TO HAVE ADDITIONAL TESTING ((B)(6) 2014) WHICH GENERATED CA125 RESULTS = 10.8 U/ML / 10.2 U/ML / NEW REAGENT LOT 10.4 U/ML. THE REPRODUCTION CENTER TOOK THE (B)(6) 2014 PATIENT'S SAMPLE TO THE REPRODUCTION CENTER FOR RETESTING, AND GENERATED CA125 = 113.600 U/ML / 118.8 U/ML. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311648 ARCHITECT CA 125 II REAGENT CANCER ANTIGEN 125 KIT LTK ABBOTT LABORATORIES 29130M500

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,| SERIAL # (B)(4)| SERIAL # (B)(4)| ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,