BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CMV IGG REAGENT KIT

    MDR report key: 22168741 · Received June 9, 2025

    Report

    Report Number
    3008344661-2025-00083
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 4, 2025
    Report Date
    July 15, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LFZ
    UDI-DI
    00380740129798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3016438761-2025-00299 UNDER A DIFFERENT SUSPECT DEVICE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-22 THAT HAS THE SAME PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P42-24/-33, WITH 510K/PMA/BLA NUMBER K220949. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING OF A RETAINED REAGENT KIT LOT 71379FZ00. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ALINITY I CMV IGG REAGENT AND COMPLAINT LOT RELATED TO THE COMPLAINT ISSUE. IN-HOUSE PERFORMANCE TESTING WAS COMPLETED ON THE COMPLAINT LOT, WHICH CONCLUDED ACCEPTANCE CRITERIA WAS MET, AND THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CMV IGG REAGENT LOT 71379FZ00 WAS IDENTIFIED.

    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
    1401862 ALINITY I CMV IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ABBOTT IRELAND DIAGNOSTICS DIVISION 71379FZ00 00380740129798

    Patients

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