BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGM REAGENT KIT

    MDR report key: 23023186 · Received September 11, 2025

    Report

    Report Number
    3002809144-2025-00291
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 6, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 7P47 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P47-40 / 45, AND 510K/PMA/BLA OF K233932. SECTION A PATIENT INFORMATION: NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I TOXO IGM, LIST NUMBER 07P47-32, AND MANUFACTURING SITE WIESBADEN, GERMANY IN SECTION D OF THIS REPORT TO ALINITY I TOXO IGM, LIST NUMBER 07P47-22, AND MANUFACTURING SITE OF WIESBADEN, GERMANY. MDR NUMBER 3002809144-2025-00312 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE ALINITY I TOXO IGM RESULTS. ON (B)(6) 2025, SID (B)(6) (CHILD SERUM), THE CUSTOMER GENERATED ALINITY I TOXO IGG NEGATIVE, ALINITY I TOXO IGM NEGATIVE, AND ELISA IGA NEGATIVE. ON (B)(6) 2025 AT ANOTHER LAB (NEONATOLOGY CLINIC OF THE (B)(6) HOSPITAL) TESTED ROCHE TOXO IGM NEGATIVE AND ROCHE TOXO IGG (64.4 IU/ML) POSITIVE ON THE CHILD SERUM. A COMPARATIVE PROFILE OF TOXOPLASMA GONDII ANTIBODIES IN MOTHER/CHILD, WAS PERFORMED AT ANOTHER LAB (POLISH NATIONAL INSTITUTE OF HYGIENE) TESTED WESTERN BLOT METHOD POSITIVE IN BOTH SERUMS. IGG AND IGM ANTIBODIES WERE PRESENT IN THE CHILD. ON (B)(6) 2025 REPEAT TEST OF THE CHILD'S SERUM SHOWED IGG AND IGM WERE NEGATIVE ON ALINITY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE ALINITY I TOXO IGM RESULTS. ON (B)(6)2025, SID (B)(6) (CHILD SERUM), THE CUSTOMER GENERATED ALINITY I TOXO IGG NEGATIVE, ALINITY I TOXO IGM NEGATIVE, AND ELISA IGA NEGATIVE. ON (B)(6) 2025 AT ANOTHER LAB (B)(6) HOSPITAL) TESTED ROCHE TOXO IGM NEGATIVE AND ROCHE TOXO IGG (64.4 IU/ML) POSITIVE ON THE CHILD SERUM. A COMPARATIVE PROFILE OF TOXOPLASMA GONDII ANTIBODIES IN MOTHER/CHILD, WAS PERFORMED AT ANOTHER LAB (POLISH NATIONAL INSTITUTE OF HYGIENE) TESTED WESTERN BLOT METHOD POSITIVE IN BOTH SERUMS. IGG AND IGM ANTIBODIES WERE PRESENT IN THE CHILD. ON (B)(6) 2025 REPEAT TEST OF THE CHILD'S SERUM SHOWED IGG AND IGM WERE NEGATIVE ON ALINITY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233510 ALINITY I TOXO IGM REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 74386BE00

    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)