BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I RUBELLA IGG REAGENT KIT

    MDR report key: 23658988 · Received November 26, 2025

    Report

    Report Number
    3008344661-2025-00165
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 3, 2025
    Report Date
    January 16, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LFX
    UDI-DI
    00380740131296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID'S ARE (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P46-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4W02-22 , WITH 510K/PMA/BLA NUMBER K243168.

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I RUBELLA IGG REAGENT LOT: 73126FZ00. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. A REVIEW OF FIELD DATA SHOWS THAT THE MEDIAN PATIENT RESULT FOR THE LOT FOR NONREACTIVE RESULTS IS COMPARABLE WITH OTHER LOTS IN THE FIELD CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I RUBELLA IGG REAGENT LOT: 73126FZ00.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I RUBELLA IGG RESULT FOR A 32 YEAR OLD PREGNANT FEMALE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING INFORMATION WAS PROVIDED: ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 4.9 IU/ML (NONREACTIVE) ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 39.6 IU/ML (REACTIVE), REPEATS = 3.7 IU/ML AND 4.2 IU/ML (NONREACTIVE), REPEAT ON ANOTHER ALINITY = 4.2 IU/ML (NONREACTIVE) ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 3.9 IU/ML (NONREACTIVE) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I RUBELLA IGG RESULT FOR A 32-YEAR-OLD PREGNANT FEMALE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING INFORMATION WAS PROVIDED: ON (B)(6) 2025, SID: (B)(6): INITIAL RESULT = 4.9 IU/ML (NONREACTIVE). ON (B)(6) 2025, SID: (B)(6): INITIAL RESULT = 39.6 IU/ML (REACTIVE), REPEATS = 3.7 IU/ML AND 4.2 IU/ML (NONREACTIVE), REPEAT ON ANOTHER ALINITY = 4.2 IU/ML (NONREACTIVE). ON (B)(6) 2025, SID: (B)(6): INITIAL RESULT = 3.9 IU/ML (NONREACTIVE) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030406 ALINITY I RUBELLA IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA LFX ABBOTT IRELAND DIAGNOSTICS DIVISION 73126FZ00 00380740131296

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6).