BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 22681282 · Received July 31, 2025

    Report

    Report Number
    3002809144-2025-00252
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    May 31, 2025
    Report Date
    July 31, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SECTION E1 - PHONE COMPLETE ENTRY = (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P45-32, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P45-45, AND A 510K NUMBER OF K210596. THE COMPLAINT INVESTIGATION FOR FALSELY DECREASED 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, AND DEVICE HISTORY RECORD REVIEW. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCT AND THE LIKELY CAUSE LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. RETURN TESTING WAS NOT COMPLETED, AS RETURNS WERE NOT AVAILABLE. TESTING OF THE COMPLAINT LOT COULD NOT BE PERFORMED SINCE THE REAGENT IS EXPIRED. INSTEAD RELEASE DATA HAS BEEN REVIEWED FOR THE COMPLAINT LOT. THE POSITIVE CONTROL 1 AND POSITIVE CONTROL 2 WERE WELL WITHIN THEIR SPECIFICATIONS, INDICATING NORMAL PERFORMANCE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ALINITY I TOXO IGG, LOT NUMBER 66439BE00, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY I TOXO IGG RESULT FOR ONE PATIENT, WHO HAS BEEN PREVIOUSLY POSITIVE. THE FOLLOWING DATA WAS PROVIDED (<1.6 IU/ML IS NONREACTIVE, >/=3.0 IU/ML IS REACTIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2025, WAS 0.4 IU/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2025, AND THE RESULT WAS 29.5 IU/ML. ADDITIONAL LABORATORY RESULTS WERE PROVIDED: TOXO IGM RESULT ON (B)(6) 2025 WAS 0.05 INDEX, WHICH IS NEGATIVE; TOXO IGM RESULT ON (B)(6) 2025 WAS 0.56 INDEX, WHICH IS GRAYZONE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224009 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 66439BE00 00380740131265

    Patients

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