BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CMV IGG

    MDR report key: 24389643 · Received February 19, 2026

    Report

    Report Number
    3008344661-2026-00037
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    February 11, 2025
    Report Date
    March 13, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LFZ
    UDI-DI
    00380740097332
    PMA / PMN Number
    K220949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3 - DATE OF EVENT: THIS SECTION WAS CORRECTED FROM 10FEB2026 TO 11FEB2025. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CMV IGG ASSAY (LIST NUMBER 06C15) DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH LIST NUMBER 06C15 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CMV IGG REAGENT WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 06C15 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06C15, WITH 510 NUMBER K220949.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT CMV IGG RESULTS WHEN COMPARED TO ANOTHER METHOD FOR ONE 50-YEAR-OLD MALE PATIENT WITH HISTORY OF POSITIVE IGG. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6) ARCHITECT CMV IGG RESULT WAS <6.0 AU/ML (NEGATIVE), CMV IGM WAS NEGATIVE. DIASORIN RESULT WAS POSITIVE 26.8 U (>15U IS POSITIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT CMV IGG RESULTS WHEN COMPARED TO ANOTHER METHOD FOR ONE 50-YEAR-OLD MALE PATIENT WITH HISTORY OF POSITIVE IGG. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6) ARCHITECT CMV IGG RESULT WAS <6.0 AU/ML (NEGATIVE), CMV IGM WAS NEGATIVE. DIASORIN RESULT WAS POSITIVE 26.8 U (>15U IS POSITIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449045 ARCHITECT CMV IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740097332

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)