BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 22043638 · Received May 19, 2025

    Report

    Report Number
    3002809144-2025-00158
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 30, 2025
    Report Date
    June 18, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131258
    PMA / PMN Number
    K210596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). SECTION E1 PHONE NUMBER COMPLETE INFORMATION: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. 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/PMA/BLA NUMBER K210596. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY REACTIVE ALINITY I TOXO IGG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF ALL THE INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED. 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 71074BE00. DEVICE HISTORY RECORD REVIEW FOR LOT 71074BE00 DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE, OR DEVIATIONS. THE OVERALL PERFORMANCE OF ALINITY I TOXO IGG REAGENT WAS REVIEWED USING WORLDWIDE FIELD DATA. THE PATIENT MEDIAN VALUES FOR THE COMPLAINT LOT IS WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I TOXO IGG REAGENT KIT FOR LOT NUMBER 71074BE00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY REACTIVE ALINITY I TOXO IGG RESULTS FOR A PREGNANT FEMALE PATIENT. THE PATIENT¿S PREVIOUS TOXO IGG AND IGM IN THE BEGINNING OF MARCH WERE BOTH NEGATIVE. (B)(6) 2025 SID (B)(6) TOXO IGG RESULT = 11.4 IU/ML, TOXO IGM = 0.05 INDEX NEGATIVE, TOXO IGG AVIDITY BLOT TEST BY MICROGEN = NEGATIVE. (B)(6) 2025 = FOLLOW UP TOXO IGG RESULTS AT 15:07 = 11.4 IU/ML AND AT 15:44 = 11.8 IU/ML, TOXO IGG RESULT SENT TO EXTERNAL LAB ON ROCHE = NEGATIVE. ADDITIONAL SAMPLE TOXO IGG RESULT = 9.9 IU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY REACTIVE ALINITY I TOXO IGG RESULTS FOR A PREGNANT FEMALE PATIENT. THE PATIENT¿S PREVIOUS TOXO IGG AND IGM IN THE BEGINNING OF (B)(6) WERE BOTH NEGATIVE. (B)(6) 2025 SID (B)(6) TOXO IGG RESULT = 11.4 IU/ML, TOXO IGM = 0.05 INDEX NEGATIVE, TOXO IGG AVIDITY BLOT TEST BY MICROGEN = NEGATIVE. (B)(6) 2025 = FOLLOW UP TOXO IGG RESULTS AT 15:07 = 11.4 IU/ML AND AT 15:44 = 11.8 IU/ML, TOXO IGG RESULT SENT TO EXTERNAL LAB ON ROCHE = NEGATIVE. ADDITIONAL SAMPLE TOXO IGG RESULT = 9.9 IU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050515 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 71074BE00 00380740131258

    Patients

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