BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG

    MDR report key: 22437268 · Received July 8, 2025

    Report

    Report Number
    3002809144-2025-00222
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 18, 2025
    Report Date
    August 22, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE ENTRY FOR SECTION A1: PATIENT IDENTIFIER: (B)(6). COMPLETE ENTRY FOR SECTION E1: PHONE NUMBER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 07P45-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 7P45-40 / 45, WITH 510K NUMBER K210596. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    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 WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I TOXO IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 73692BE00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER. THE OVERALL PERFORMANCE OF ALINITY I TOXO IGG REAGENTS IN THE FIELD WAS REVIEWED USING DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES FOR THE COMPLAINT LOT ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOXO IGG REAGENT LOT 73692BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I TOXO IGG FOR ONE FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID: (B)(6), INITIAL TOXO-IGG RESULT= 3.5 U/ML; HISTORICAL RESULT= NEGATIVE; ON (B)(6) 2025, THE SAMPLE WAS REPEATED TWICE, RESULTS= 0.1 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I TOXO IGG FOR ONE FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL TOXO-IGG RESULT= 3.5 U/ML; HISTORICAL RESULT= NEGATIVE; (B)(6) 2025, THE SAMPLE WAS REPEATED TWICE, RESULTS= 0.1 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387628 ALINITY I TOXO IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 73692BE00 00380740131258

    Patients

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