BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT AFP

    MDR report key: 4250590 · Received November 14, 2014

    Report

    Report Number
    3008344661-2014-00041
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 27, 2014
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOK
    PMA / PMN Number
    P120008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A BATCH RECORD REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE. REVIEW OF THE CUSTOMERS' PROVIDED DATA WAS REVIEWED. REVIEW OF THE DATA CONFIRMED THE CUSTOMER'S OBSERVATION. AN ACCURACY TESTING PROTOCOL WAS EXECUTED WITH FILE KIT MATERIAL OF ARCHITECT AFP REAGENT LOT 40169LF00. THE TESTING MET THE ACCEPTANCE REQUIREMENTS WHICH INDICATED THAT THE LOT WAS PERFORMING AS INTENDED. THE BATCH RECORD REVIEW FOUND NO ISSUES. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION A DEFICIENCY OF THE ARCHITECT AFP REAGENT, LOT NUMBER 40169LF00, WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED AFP RESULT FOR ONE PATIENT (SID (B)(6)) WHILE USING THE ARCHITECT AFP ASSAY. THE CUSTOMER INDICATED THE INITIAL AFP RESULT WAS 936.11 NG/ML GENERATED ON (B)(6) 2014. A NEW SPECIMEN WAS DRAWN AND GENERATED A RESULT OF 2.6 NG/ML. ON (B)(6) 2014, THE PATIENT WAS RETESTED AND GENERATED A RESULT OF 2.55 NG/ML. THE ORIGINAL SPECIMEN HAD BEEN DISCARDED AND COULD NOT BE RETESTED. IT WAS INDICATED THAT ADDITIONAL TESTS WERE RUN FOR THIS PATIENT AFTER THE INITIAL RESULT WAS GENERATED, NO ABNORMALITIES WERE IDENTIFIED. NO DETAILS TO WHAT ADDITIONAL TESTS WERE RUN WERE PROVIDED. THE AFP TEST WAS PERFORMED AS PART OF THE PATIENTS' PHYSICAL EXAM AND WAS NOT FOR USE FOR PREGNANCY OR ONCOLOGY TESTING. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737401 ARCHITECT AFP ALPHA-FETOPROTEIN LOK ABBOTT IRELAND 40169LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| LN 03M74-02, SN (B)(4)