BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 22786055 · Received August 12, 2025

    Report

    Report Number
    3002809144-2025-00261
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 9, 2025
    Report Date
    October 2, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 07P45-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 7P45-40 / 45, WITH 510K/PMA/BLA NUMBER: K210596. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6).

    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, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW, AND IN-HOUSE TESTING. 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 71075BE00. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS WITH LOT 71075BE00. THE OVERALL PERFORMANCE OF ALINITY I TOXO IGG REAGENT WAS REVIEWED USING WORLDWIDE FIELD DATA. THE PATIENT MEDIAN VALUES FOR THE COMPLAINT LOT ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED. ALL SPECIFICATIONS WERE MET, AND NO FALSE REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I TOXO IGG REAGENT KIT FOR LOT NUMBER 71075BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I TOXO IGG. THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE (B)(6) RESULT WAS 100.3 IU/ML (REACTIVE). WHEN SAMPLE WAS REPEATED ON (B)(6) 2025, THE RESULT WAS 110.6 IU/ML (REACTIVE). WHEN TESTED ON THE DIASORIN PLATFORM, TOXO IGG WAS <3 IU/ML (NEGATIVE). TOXO IGM WAS ALSO TESTED ON THE DIASORIN PLATFORM, WHICH GENERATED A RESULT OF <3 AU/ML (NEGATIVE). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ALINITY I TOXO IGG. THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE (B)(6) RESULT WAS 100.3 IU/ML (REACTIVE). WHEN SAMPLE WAS REPEATED ON (B)(6) 2025, THE RESULT WAS 110.6 IU/ML (REACTIVE). WHEN TESTED ON THE DIASORIN PLATFORM, TOXO IGG WAS <3 IU/ML (NEGATIVE). TOXO IGM WAS ALSO TESTED ON THE DIASORIN PLATFORM, WHICH GENERATED A RESULT OF <3 AU/ML (NEGATIVE). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379349 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 71075BE00

    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).