BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CMV IGG REAGENT KIT

    MDR report key: 21935882 · Received April 30, 2025

    Report

    Report Number
    3008344661-2025-00053
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 12, 2025
    Report Date
    April 30, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LFZ
    UDI-DI
    00380740129798
    PMA / PMN Number
    K220949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6). THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY I CMV IGG LOT# 64302FN00 IDENTIFIED HIGHER COMPLAINT ACTIVITY THAN EXPECTED, BUT TRENDING REVIEW DETERMINED THERE WERE NO TRENDS FOR THE ISSUE FOR THIS PRODUCT. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 64302FN00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P42-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24, WITH 510K/PMA/BLA NUMBER K220949.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I CMV IGG RESULT ON A 15-YR OLD MALE PATIENT. RESULTS PROVIDED: (B)(6) 2025 , SID (B)(6) , CMV IGG = 9.2 / 1.4 / 17.4 AU/ML, ANOTHER LABORATORY = 1.6 AU/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2414002 ALINITY I CMV IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ABBOTT IRELAND DIAGNOSTICS DIVISION 64302FZ00 00380740129798

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6)