BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 21801004 · Received April 8, 2025

    Report

    Report Number
    3002809144-2025-00126
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 28, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131265
    PMA / PMN Number
    K210596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 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.

    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, IN HOUSE TESTING OF A RETAINED REAGENT KIT LOT 66439BE00 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. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I PROCESSING MODULE 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 66439BE00. 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 66439BE00 IS WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. IN-HOUSE TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. 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 66439BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOXO IGG RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (>3.0 U/ML IS REACTIVE): ON (B)(6) 2025, SID (B)(6), INITIAL RESULT 7.8 U/ML, REPEATED 0.1 AND 0.2 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOXO IGG RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (>3.0 U/ML IS REACTIVE): (B)(6) 2025 SID (B)(6) INITIAL RESULT 7.8 U/ML, REPEATED 0.1 AND 0.2 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727810 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).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).