BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM ALPHA FETOPROTEIN (AFP)

    MDR report key: 23715140 · Received December 4, 2025

    Report

    Report Number
    1219913-2025-00216
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 25, 2025
    Report Date
    January 29, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOK
    UDI-DI
    00630414597706
    PMA / PMN Number
    P930036-S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 1219913-2025-00216. INITIAL REPORT WAS FILED ON 04-DEC-2025. ADDITIONAL INFORMATION: THE CUSTOMER CONTACT NAME AND PHONE NUMBER WERE RECEIVED. SECTION E1 OF THIS SUPPLEMENTAL REPORT CONTAINS THE INFORMATION. PATIENT INFORMATION WAS RECEIVED. SECTIONS A3 AND B7 OF THIS SUPPLEMENTAL REPORT CONTAIN THE ADDITIONAL INFORMATION. SIEMENS CONTINUES TO INVESTIGATE.

    Additional Manufacturer Narrative · 0

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM ALPHA FETOPROTEIN (AFP) RESULT ON ONE PATIENT SAMPLE RELATIVE TO LOWER RETEST RESULTS. THE INITIAL ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED ON A DIFFERENT ATELLICA IM ANALYZER, AND THE RESULT WAS LOWER. THE SAMPLE WAS TESTED AGAIN ON THE INITIAL ATELLICA IM ANALYZER, AND THE RESULT WAS ALSO LOWER. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT. PATIENT INFORMATION HAS NOT BEEN PROVIDED. PER THE ASSAY INSTRUCTIONS FOR USE (IFU), "THE ATELLICA IM AFP ASSAY IS NOT A SCREENING TEST FOR CANCER AND MUST NEVER BE USED AS SUCH." "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING. NOTE: THIS OUS PRODUCT (CATALOG NUMBER 10995441, AS LISTED IN D4 OF THIS REPORT) IS ASSOCIATED WITH SIMILAR PRODUCT IN THE UNITED STATES (CATALOG NUMBER 11202257). SECTION G4 OF THIS REPORT LISTS THE PREMARKET APPROVAL (PMA) NUMBER OF THIS SIMILAR US PRODUCT (P930036-S009).

    Additional Manufacturer Narrative · 0

    SIEMENS COMPLETED THE INVESTIGATION FOR AN ELEVATED ATELLICA IM ALPHA FETOPROTEIN (AFP) LOT 288 RESULT FOR ONE PATIENT WHICH WAS DISCORDANT RELATIVE TO RETEST RESULTS. THE LOWER RETEST RESULTS WERE CONSIDERED CORRECT. THE INVESTIGATION INCLUDED AN ASSESSMENT OF THE FOLLOWING: SIEMENS REVIEWED QUALITY CONTROL (QC) AND CALIBRATIONS, AND ALL RESULTS WERE ACCEPTABLE ON THE DAY OF THE DISCREPANCY. SIEMENS REVIEWED INTERNAL REAGENT RELEASE DATA FOR ATELLICA IM AFP REAGENT LOT 288 AND ALL SPECIFICATIONS WERE MET. SIEMENS REVIEWED INSTRUMENT TRACE FILES RELATED TO THE SAMPLE IN QUESTION AND NO INSTRUMENT PROBLEMS WERE IDENTIFIED. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT REQUIRED AS THE INITIAL DISCORDANT RESULT WAS NOT REPRODUCED. THE CUSTOMER HAS NOT HAD ANY SIMILAR ISSUES. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT CANNOT BE DETERMINED BUT APPEARS TO BE AN ISOLATED SAMPLE ISSUE. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE RETESTING / TROUBLESHOOTING. SIEMENS FILED MDR INITIAL REPORT ON 04-DEC-2025 AND MDR SUPPLEMENTAL 1 REPORT ON 08-DEC-2025. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM ALPHA FETOPROTEIN (AFP) RESULT ON ONE PATIENT SAMPLE RELATIVE TO LOWER RETEST RESULTS. THE INITIAL ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED ON A DIFFERENT ATELLICA IM ANALYZER, AND THE RESULT WAS LOWER. THE SAMPLE WAS TESTED AGAIN ON THE INITIAL ATELLICA IM ANALYZER, AND THE RESULT WAS ALSO LOWER. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622926 ATELLICA IM ALPHA FETOPROTEIN (AFP) KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS LOK SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 29427288 00630414597706

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male