BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 22059370 · Received May 21, 2025

    Report

    Report Number
    3016438761-2025-00299
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    May 4, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I PROCESSING MODULE, LIST 03R65, ABBOTT LABORATORIES, IRVING, TEXAS, USA TO ALINITY I CMV IGG, LIST 07P42, ABBOTT IRELAND DIAGNOSTICS DIVISION, SLIGO, IRELAND. MDR NUMBER 3008344661-2025-00083 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE SAMPLE WAS REPEATED, AND NONREACTIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 7.8 AU/ML (REACTIVE), REPEAT RESULTS = 1.2 AU/ML (NONREACTIVE) AND 1.2 AU/ML (NONREACTIVE). PER THE ALINITY I CMV IGG PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION: SPECIMENS WITH CONCENTRATION VALUES = 6.0 AU/ML ARE CONSIDERED REACTIVE AND < 6.0 AU/ML ARE CONSIDERED NONREACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE SAMPLE WAS REPEATED, AND NONREACTIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 7.8 AU/ML (REACTIVE). REPEAT RESULTS = 1.2 AU/ML (NONREACTIVE) AND 1.2 AU/ML (NONREACTIVE). PER THE ALINITY I CMV IGG PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION: SPECIMENS WITH CONCENTRATION VALUES = 6.0 AU/ML ARE CONSIDERED REACTIVE AND < 6.0 AU/ML ARE CONSIDERED NONREACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885454 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I CMV IGG 200T, 07P42-22, 71379FZ00| ALNTY I CMV IGG 200T, 07P42-22, 71379FZ00