BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 20939757 · Received December 16, 2024

    Report

    Report Number
    3002809144-2024-00355
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 23, 2024
    Report Date
    December 20, 2024
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    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

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY I TOXO IGG REAGENT LOT 64052BE00 IDENTIFIED NORMAL COMPLAINT ACTIVITY AND THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. CLINICAL SENSITIVITY OF THE ALINITY I TOXO IGG ASSAY HAS BEEN EVALUATED WITH A RETAINED IN-HOUSE KIT OF THE SAME LOT# 64052BE00 AND MET ALL SPECIFICATIONS, CONFIRMING THAT THIS LOT IS MEETING THE ALINITY I TOXO IGG PRODUCT REQUIREMENTS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMERS OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I TOXO IGG KIT (LOT# 64052BE00).

    Additional Manufacturer Narrative · 0

    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. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P45-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P45-45 WITH 510K/PMA/BLA NUMBER K210596.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I TOXO IGG RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2024, SID (B)(6) = 0.2 IU/ML (NO TOXO AVIDITY TEST PERFORMED ON THE INITIAL SAMPLE), REPEATED ON ANOTHER ALINITY ON (B)(6)2024 = 67.9 IU/ML, TOXO AVIDITY = 78.9%. PREVIOUS TOXO-G RESULT ON (B)(6) 2024 = 70.60 IU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I TOXO IGG RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6) = 0.2 IU/ML (NO TOXO AVIDITY TEST PERFORMED ON THE INITIAL SAMPLE), REPEATED ON ANOTHER ALINITY ON (B)(6) 2024 = 67.9 IU/ML, TOXO AVIDITY = 78.9% PREVIOUS TOXO-G RESULT ON (B)(6) 2024 = 70.60 IU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328997 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 64052BE00

    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)