BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT AFP

    MDR report key: 2446979 · Received February 13, 2012

    Report

    Report Number
    3008344661-2012-00007
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 23, 2012
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOK
    PMA / PMN Number
    P820060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT TRENDING DETERMINED NORMAL COMPLAINT ACTIVITY FOR ARCHITECT AFP REAGENT LOT 10480LF00 AND NO DEFICIENCY OR ADVERSE TRENDS WERE IDENTIFIED WITH THIS REAGENT LOT, AND THE REAGENT WAS PERFORMING AS EXPECTED. THE ARCHITECT SYSTEM MANUAL TROUBLESHOOTING AND DIAGNOSTICS SECTION WAS REVIEWED AND CONTAINED ADEQUATE INFORMATION REGARDING MULTIPLE CAUSES AND TROUBLESHOOTING STEPS FOR FALSELY DEPRESSED RESULTS. REVIEW OF THE CUSTOMER'S INSTRUMENT DATA DETERMINED NO UNUSUAL CALIBRATION ISSUES. THE CUSTOMER'S ISSUE WAS RELATED TO THE AFP ASSAY DESIGN. IN 2008, A PRODUCT CORRECTION WAS ISSUED BY ABBOTT WITH INFORMATION REGARDING THE RESTANDARDIZATION OF THE AFP ASSAY AND A DISCREPANCY THAT MAY OCCUR; FOLLOW UP INFORMATION LETTERS WERE DISTRIBUTED WITH DETAILED UPDATES TO PREVENT THE ANALYZER FROM REPORTING CONCENTRATIONS BETWEEN 3340 NG/ML AND 5845 NG/ML (SPECIMENS READING BETWEEN 200 - 350 NG/ML ON THE CALIBRATION CURVE. THIS CHANGE ENABLED DIRECT INTERPRETATION OF REPORTED VALUES, (WHICH WOULD HAVE ALLOWED THE CUSTOMER TO CHANGE THE HIGH LINEARITY OF THE AFP ASSAY), OR ALLOW FOR THE CONFIGURATION RETEST RULE WHICH AUTOMATICALLY RE-ORDERS PATIENT SAMPLES READING >200 NG/ML. PRODUCT INFORMATION IN PRODUCT NOTIFICATIONS WERE INCLUDED IN EACH REAGENT KIT/ REAGENT SHIPMENTS REGARDING HIGH LINEARITY DILUTION OPTIONS AND UPDATES THAT ENABLED DIRECT INTERPRETATION OF REPORTED VALUES WHICH WAS IN ALIGNMENT WITH INSTRUCTIONS PROVIDED IN THE 2008 PRODUCT CORRECTION LETTER. A NEW AFP ASSAY IS NOW AVAILABLE WHICH HAS AN EXTENDED DYNAMIC RANGE UP TO 2000NG/ML.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, IT WAS DISCOVERED THAT AN EMDR WAS NOT REQUIRED FOR THIS INCIDENT AS THE MEDICAL DEVICE IN QUESTION (ARCHITECT AFP, LIST 07K67-27) IS NOT DISTRIBUTED IN THE U.S. AND HAS NO SIMILAR U.S. DISTRIBUTED PRODUCT. THE INITIAL AND FOLLOW-UP # 01 EMDRS WERE SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A FALSELY DEPRESSED ARCHITECT AFP RESULT OF 264.27 NG/ML WAS GENERATED FOR A PEDIATRIC ONCOLOGY PATIENT WITH A KNOWN HISTORY OF VERY HIGH AFP VALUES. THE PEDIATRIC ONCOLOGIST REQUESTED THE SAMPLE TO BE RERUN WITH THE SAME SAMPLE AND REAGENTS. THE FOLLOWING RESULTS IN NG/ML WERE GENERATED SINCE (B)(6) 2011: (B)(6) 2011: 7000, (B)(6) 2011: 35350, (B)(6) 2011: 35000, (B)(6) 2012: 264.27, (B)(6) 2012: >350, (B)(6) 2012: >3340 (DILUTED 1:16.7), 53707.76 (MANUALLY DILUTED 1:101, RESULT NOT REPORTED), (B)(6) 2012: >35350, (B)(6) 2012: 49553 (DILUTION OF 1:16.7), (B)(6) 2012: 32544. TROUBLESHOOTING OF THE ISSUE INCLUDED REVIEW OF THE ANALYZER MAINTENANCE WHICH SHOWED DAILY MAINTENANCE WAS PERFORMED, QUALITY CONTROLS WERE NORMAL, STABILITY OF ON-BOARD REAGENTS WAS ACCEPTABLE, AND THE LINEARITY OF THE ASSAY WAS CONSISTENT WITH THE REAGENT PACKAGE INSERT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT AFP LOK ABBOTT IRELAND 10480LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR ARCHITECT I1000SR, LIST #1L86-01, SN (B)(4)| ARCHITECT I1000SR LIST # 1L86-01| SERIAL # (B)(4)| ARCHITECT I1000SR, LIST # 1L86-01, SN (B)(4)