BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CMV IGG REAGENT KIT

    MDR report key: 22894332 · Received August 26, 2025

    Report

    Report Number
    3008344661-2025-00121
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    August 18, 2025
    Report Date
    October 16, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LFZ
    UDI-DI
    00380740129798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P44-22/32, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, WITH 510K/PMA/BLA NUMBER K220949. COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, SPECIFICITY TESTING AND DEVICE HISTORY RECORD REVIEW FOR ALINITY I CMV IGG REAGENT LOT NUMBER 74399FZ00. 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 FOR THE ALINITY I CMV IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 74399FZ00. CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAIN KIT OF ALINITY I CMV IGG REAGENT LOT 74399FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT(S) AND COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I CMV IGG REAGENT LOT NUMBER 74399FZ00.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS ON A FEMALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2025, SID (B)(6), INITIAL=> 250.0 AU/ML (>OR=6.0 AU/ML=REACTIVE) /REPEATED 1:10 DILUTION=< 11.0 AU/ML AND < 11.0 AU/ML (< 6.0 AU/ML=NONREACTIVE). REPEATED ON (B)(6) 2025 1:10 DILUTION=< 11.0 AND < 11.0 AU/ML /REPEATED NEAT=0.54 AND 0.48 AU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS ON A FEMALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) INITIAL=> 250.0 AU/ML (>OR=6.0 AU/ML=REACTIVE) /REPEATED 1:10 DILUTION=< 11.0 AU/ML AND < 11.0 AU/ML (< 6.0 AU/ML=NONREACTIVE) REPEATED ON (B)(6) 2025 1:10 DILUTION=< 11.0 AND < 11.0 AU/ML /REPEATED NEAT=0.54 AND 0.48 AU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609237 ALINITY I CMV IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ABBOTT IRELAND DIAGNOSTICS DIVISION 74399FZ00 00380740129798

    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)