BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM ALPHA FETOPROTEIN (AFP)

    MDR report key: 21938809 · Received April 30, 2025

    Report

    Report Number
    1219913-2025-00090
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 30, 2025
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). SIMENS INVESTIGATED AN OUS CUSTOMER ALLEGATION OF A DISCORDANT (FALSELY DEPRESSED) ATELLICA IM ALPHA FETOPROTEIN (AFP) LOT 285 PATIENT SAMPLE RESULT. AN INITIAL RESULT OF 593 NG/ML WAS OBTAINED (WITHIN THE ASSAY ANALYTICAL MEASURING RANGE (AMR)). THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN BECAUSE IT CONFLICTED WITH THE PATIENT'S CLINICAL HISTORY. THE CUSTOMER RETESTED THE SAMPLE BY AUTO-DILUTION AND THE RESULT (1,806,757 NG/ML) WAS GREATER THAN THE AMR AND WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT. SIEMENS REVIEWED THE COMPLAINT INFORMATION AND PROVIDED THE CUSTOMER WITH EXPLANATION REGARDING HOOK EFFECT LIMITATIONS FOR THIS ASSAY. THE CONCENTRATION OF THE PATIENT IN QUESTION WAS AS HIGH AS 1,806,757 NG/ML ONCE DILUTED, THEREFORE THE NEAT VALUE COULD READ LESS THAN LINEARITY REPRESENTING HOOK EFFECT. PER THE INSTRUCTIONS FOR USE (IFU): "HIGH-DOSE HOOK EFFECT HIGH AFP CONCENTRATIONS CAN CAUSE A PARADOXICAL DECREASE IN THE RLUS (HIGH-DOSE HOOK EFFECT). IN THIS ASSAY, PATIENT SAMPLES WITH AFP CONCENTRATIONS AS HIGH AS 460,000 NG/ML (381,800 IU/ML) WILL REPORT > 1,000.0 NG/ML (830.00 IU/ML)." THE CUSTOMER UNDERSTOOD AND DECLINED ANY FURTHER TROUBLESHOOTING ASSISTANCE. THE INVESTIGATION CONFIRMED THAT THERE IS NO PRODUCT MALFUNCTION. A PRODUCT ISSUE WAS NOT IDENTIFIED, AND THE CUSTOMER IS OPERATIONAL. NOTE: THIS OUS PRODUCT (CATALOG NUMBER 110995441, 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)# P930036-S009 OF THIS SIMILAR US PRODUCT.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGES A DISCORDANT (FALSELY DEPRESSED) ATELLICA IM ALPHA FETOPROTEIN (AFP) LOT 285 PATIENT SAMPLE RESULT. AN INITIAL RESULT WAS OBTAINED THAT WAS WITHIN THE ASSAY ANALYTICAL MEASURING RANGE (AMR). THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN BECAUSE IT CONFLICTED WITH THE PATIENT'S CLINICAL HISTORY. THE CUSTOMER RETESTED THE SAMPLE BY AUTO-DILUTION AND THE RESULT WAS GREATER THAN THE AMR AND WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185810 ATELLICA IM ALPHA FETOPROTEIN (AFP) KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS LOK SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 42918285 00630414597706

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male