BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG

    MDR report key: 22395772 · Received July 3, 2025

    Report

    Report Number
    3002809144-2025-00213
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    May 7, 2025
    Report Date
    August 18, 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 A PATIENT INFORMATION: IDENTIFIER OF MULTIPLE IS SAMPLE IDS (B)(6). NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P45-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P45-40/-45, AND 510K/PMA/BLA OF K210596. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    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, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. ¿¿¿¿¿¿¿THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE TICKET TRENDING REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ALINITY I TOXO IGG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES OBTAINED WITH THE COMPLAINT LOT 69140BE00 IS WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOXO IGG REAGENT LOT 69140BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I TOXO IGG RESULTS A PATIENT. ON (B)(6) 2025, ID (B)(6), GENERATED 0.10 IU/ML NONREACTIVE ON (B)(6) 2025, ID (B)(6), GENERATED 4.89 IU/ML REACTIVE ON (B)(6) 2025, ID (B)(6), GENERATED 9.25 IU/ML REACTIVE ON (B)(6) 2025, ID (B)(6), GENERATED 17.49 IU/ML REACTIVE THE CUSTOMER OBSERVED A GRADUAL INCREASE IN TOXO IGG LEVEL, WITH IGM NONREACTIVE. REACTIVITY NOT CONFIRMED BY AN IMMUNOBLOT FROM LDBIO DIAGNOSTICS. REACTIVITY NOT CONFIRMED ON DIASORIN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I TOXO IGG RESULTS A PATIENT. (B)(6) 2025 ID (B)(6) GENERATED 0.10 IU/ML NONREACTIVE (B)(6) 2025 ID (B)(6) GENERATED 4.89 IU/ML REACTIVE (B)(6) 2025 ID (B)(6) GENERATED 9.25 IU/ML REACTIVE (B)(6) 2025 ID (B)(6) GENERATED 17.49 IU/ML REACTIVE THE CUSTOMER OBSERVED A GRADUAL INCREASE IN TOXO IGG LEVEL, WITH IGM NONREACTIVE. REACTIVITY NOT CONFIRMED BY AN IMMUNOBLOT FROM LDBIO DIAGNOSTICS. REACTIVITY NOT CONFIRMED ON DIASORIN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845028 ALINITY I TOXO IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 69140BE00 00380740131265

    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)