BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I RUBELLA IGG REAGENT KIT

    MDR report key: 23498887 · Received November 7, 2025

    Report

    Report Number
    3008344661-2025-00156
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 29, 2025
    Report Date
    January 6, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LFX
    UDI-DI
    00380740131302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I RUBELLA IGG REAGENT LOT 73122FZ00. 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. CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAIN KIT OF LOT 73122FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. 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 73122FZ00.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P46-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P46, WITH 510K NUMBER K243168. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 PATIENT IDENTIFIER: SAMPLE ID IS (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I RUBELLA IGG RESULTS FOR ONE FEMALE PATIENT WHO WAS BEING MONITORED FOR PREGNANCY. THE PATIENT HAS A NEGATIVE MEDICAL HISTORY AND IS UNVACCINATED. THE DISCREPANT RESULT WAS NOT REPORTED OUT OF THE LAB. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT 72.5 IU/ML (REACTIVE), REPEATED 1.9 AND 1.9 IU/ML (NONREACTIVE). (REFERENCE RANGE 0.0 TO 4.9 IS NONREACTIVE, 5.0 TO 9.9 IS GRAYZONE, = 10.019 IS REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I RUBELLA IGG RESULTS FOR ONE FEMALE PATIENT WHO WAS BEING MONITORED FOR PREGNANCY. THE PATIENT HAS A NEGATIVE MEDICAL HISTORY AND IS UNVACCINATED. THE DISCREPANT RESULT WAS NOT REPORTED OUT OF THE LAB. THE FOLLOWING DATA WAS PROVIDED: SID (B)(60, INITIAL RESULT 72.5 IU/ML (REACTIVE), REPEATED 1.9 AND 1.9 IU/ML (NONREACTIVE). (REFERENCE RANGE 0.0 TO 4.9 IS NONREACTIVE, 5.0 TO 9.9 IS GRAYZONE, = 10.019 IS REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268671 ALINITY I RUBELLA IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA LFX ABBOTT IRELAND DIAGNOSTICS DIVISION 73122FZ00 00380740131302

    Patients

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