BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 22043818 · Received May 19, 2025

    Report

    Report Number
    3002809144-2025-00159
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 25, 2025
    Report Date
    July 7, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131265
    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

    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 NUMBER: K210596. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    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, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING 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 TOXO IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY REGARDING COMMONALITIES FOR LOT NUMBER AND ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 69140BE00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF LOT 69139BE, WHICH CONTAINS THE SAME BULK MATERIAL AS THE COMPLAINT LOT, WAS PERFORMED. ALL SPECIFICATIONS WERE MET AND NO FALSE REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. ONE COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (ID 461957152) WAS TESTED AND SEROCONVERSION PANEL RESULTS WERE COMPARED TO THE HISTORICAL RESULTS LISTED IN THE INSTRUCTIONS FOR USE (IFU) OF THE ALINITY I TOXO IGG REAGENT. THE REAGENT LOT 69139BE00 DETECTED THE SAME BLEEDS AS REACTIVE IN COMPARISON TO HISTORICAL LOTS. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. 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 NON-REACTIVE ALINITY I TOXO IGG FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID: (B)(6), ON (B)(6) 2025, TOXO IGG= 0.1 IU/ML (NON-REACTIVE), WHICH WAS QUESTIONED BY THE PHYSICIAN BECAUSE THE PATIENT HAD A HISTORY OF BEING POSITIVE. ON (B)(6) 2025, REPEAT RESULTS= 62.7 IU/ML, 71.3 IU/ML, 68.2 IU/ML, 71.6 IU/ML (REACTIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NON-REACTIVE ALINITY I TOXO IGG FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), (B)(6) 2025, TOXO IGG= 0.1 IU/ML (NON-REACTIVE), WHICH WAS QUESTIONED BY THE PHYSICIAN BECAUSE THE PATIENT HAD A HISTORY OF BEING POSITIVE. ON (B)(6) 2025, REPEAT RESULTS= 62.7 IU/ML, 71.3 IU/ML, 68.2 IU/ML, 71.6 IU/ML (REACTIVE) . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049545 ALINITY I TOXO IGG REAGENT KIT 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)