BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 22419699 · Received July 7, 2025

    Report

    Report Number
    3002809144-2025-00216
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 7, 2025
    Report Date
    August 6, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131258
    PMA / PMN Number
    K210596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = SAMPLE ID (B)(6) AND SAMPLE ID (B)(6) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P45-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P45-40, AND A 510K NUMBER OF K210596.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED 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. THE OVERALL PERFORMANCE OF ALINITY I TOXO IGG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE MEDIAN VALUES FOR THE COMPLAINT LOT ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT 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 69139BE00, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I TOXO IGG RESULT FOR ONE PATIENT. 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), WAS 5.5 IU/ML, WHICH WAS RELEASED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER THE RESULT WAS 1.0 IU/ML. THE PATIENT WAS RECOLLECTED, ON (B)(6) UNDER SAMPLE ID (B)(6), INITIAL RESULT WAS 0.0, REPEAT, ON ANOTHER ANALYZER, WAS 0.0 IU/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 RESULT FOR ONE PATIENT. 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), WAS 5.5 IU/ML, WHICH WAS RELEASED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED, AND THE RESULT WAS 0.0 IU/ML. THE PATIENT WAS RECOLLECTED, ON (B)(6) UNDER SAMPLE ID (B)(6), INITIAL RESULT WAS 0.0, REPEAT, ON ANOTHER ANALYZER, WAS 0.0 AND 1.0 IU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176122 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 69139BE00 00380740131258

    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)