BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I AFP REAGENT KIT

    MDR report key: 23586272 · Received November 18, 2025

    Report

    Report Number
    3008344661-2025-00160
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 16, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOK
    UDI-DI
    00380740210526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. CONTINUED INFORMATION FOR SECTION A1: (B)(6) AND E1 PHONE NUMBER: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS WERE NOT PROVIDED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P90-21 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P90-20, PMA# P120008.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW, AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THE LOT IS PERFORMING AS EXPECTED. TICKET TRENDING REVIEW FOR THE LIST NUMBER DID NOT IDENTIFY ANY TRENDS. A DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER. A REVIEW OF DATA GATHERED FROM CUSTOMERS WORLDWIDE SHOWS THE MEDIAN PATIENT RESULT FOR LOT 75169FZ00 IS COMPARABLE WITH OTHER LOTS IN THE FIELD AND WITHIN ESTABLISHED BASELINES. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I AFP REAGENT LOT 75619FZ00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I AFP RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR ONE PATIENT WITH UNKNOWN DIAGNOSIS. SID (B)(6) INITIAL RESULT = 78.79 NG/ML, REPEAT RESULTS = 2.36 NG/ML AND 2.31 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I AFP RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR ONE PATIENT WITH UNKNOWN DIAGNOSIS. SID (B)(6) INITIAL RESULT = 78.79 NG/ML, REPEAT RESULTS = 2.36 NG/ML AND 2.31 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330057 ALINITY I AFP REAGENT KIT KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS LOK ABBOTT IRELAND DIAGNOSTICS DIVISION 75169FZ00 00380740210526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).