BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 20855674 · Received December 5, 2024

    Report

    Report Number
    3002809144-2024-00345
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 6, 2024
    Report Date
    January 27, 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 07P45-32THAT 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, 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 LIST INDICATES THAT THE COMPLAINT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS REGARDING COMMONALITIES FOR COMPLAINT LOT. 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 LIST 07P45-32 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 LIST 07P45-32, LOT UNKNOWN WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOXO IGG RESULTS FOR TWO PATIENTS WHEN COMPARED TO OTHER METHODS. BOTH SAMPLES HAD A POSITIVE ALINITY I TOXO IGG RESULT WITH VALUES OF 4 AND 5. BOTH SAMPLES TESTED NEGATIVE ON ICT LDBIO DIAGNOSTICS AND WESTERN BLOT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOXO IGG RESULTS FOR TWO PATIENTS WHEN COMPARED TO OTHER METHODS. BOTH SAMPLES HAD A POSITIVE ALINITY I TOXO IGG RESULT WITH VALUES OF 4 AND 5. BOTH SAMPLES TESTED NEGATIVE ON ICT LDBIO DIAGNOSTICS AND WESTERN BLOT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114576 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 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)