BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM ALPHA FETOPROTEIN (AFP)

    MDR report key: 22139566 · Received June 4, 2025

    Report

    Report Number
    1219913-2025-00108
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 20, 2025
    Report Date
    July 18, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOK
    UDI-DI
    00630414597713
    PMA / PMN Number
    P930036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES (OUS) REPORTED OBSERVATION OF ELEVATED ATELLICA IM ALPHA FETOPROTEIN (AFP) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS EVALUATING THIS ISSUE.

    Additional Manufacturer Narrative · 0

    MDR 1219913-2025-00108 WAS INITIALLY FILED ON 04-JUN-2025. ADDITIONAL INFORMATION (24-JUN-2025): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. A CUSTOMER FROM OUTSIDE THE UNITED STATES (OUS) REPORTED OBSERVATION OF ELEVATED ATELLICA IM ALPHA FETOPROTEIN (AFP) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS EVALUATED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. SIEMENS DID NOT IDENTIFY ANY PIPETTING ERRORS FOR THE SAMPLE OR REAGENT BUT OBSERVED CHANGES IN PRESSURE AND VALVES. SERVICE WAS DISPATCHED TO THE CUSTOMER SITE. THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE) INSPECTED THE INSTRUMENT AND REPAIRED THE WASH RING AS PART OF ROUTINE TROUBLESHOOTING ACTIVITIES AND NO FURTHER ISSUES WERE OBSERVED. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT WAS UNDETERMINED. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED OBSERVATION OF ELEVATED ATELLICA IM ALPHA FETOPROTEIN (AFP) PATIENT RESULTS WHEN USING REAGENT LOT# 285, WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON THE SAME ATELLICA IM ANALYZER AND OBTAINED LOWER RESULTS. THESE LOWER RESULTS WERE IN AGREEMENT WITH THE CLINICAL PICTURE OF THE AFFECTED PATIENTS, WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588536 ATELLICA IM ALPHA FETOPROTEIN (AFP) ATELLICA IM ALPHA FETOPROTEIN (AFP) LOK SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 42919285 00630414597713

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown