BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CMV IGG REAGENT KIT

    MDR report key: 20689334 · Received November 14, 2024

    Report

    Report Number
    3008344661-2024-00136
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 30, 2024
    Report Date
    February 6, 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
    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 07P42-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33 WITH 510K/PMA/BLA NUMBER K220949. 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. 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. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR THE ALINITY I CMV IGG REAGENT HOWEVER THE SEARCH DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE COMPLAINT LOT. IN-HOUSE PERFORMANCE TESTING WAS COMPLETED WHICH CONCLUDED ALL SPECIFICATIONS WERE MET AND THE COMPLAINT LOT 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 64302FZ00 IDENTIFIED.

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: COMPLETE LIST OF SAMPLE ID'S 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 AND PROVIDED THE FOLLOWING DATA FOR 2 PATIENTS: CUSTOMER REFERENCE = 6.0 AU/ML IS REACTIVE SAMPLE ID (B)(6): ON (B)(6) 2024, INITIAL RESULT WAS 67.6 AU/ML AND WHEN REPEATED ON (B)(6) 2024, THE RESULT WAS 0.05 AU/ML. SAMPLE ID (B)(6): ON (B)(6) 2024, INITIAL RESULT WAS 18.2AU/ML AND WHEN REPEATED ON (B)(6) 2024, THE RESULT WAS 0.3 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 AND PROVIDED THE FOLLOWING DATA FOR 2 PATIENTS: CUSTOMER REFERENCE = 6.0 AU/ML IS REACTIVE. SAMPLE ID (B)(6): ON (B)(6) 2024, INITIAL RESULT WAS 67.6 AU/ML AND WHEN REPEATED ON (B)(6) 2024, THE RESULT WAS 0.05 AU/ML. SAMPLE ID (B)(6) : ON (B)(6) 2024, INITIAL RESULT WAS 18.2AU/ML AND WHEN REPEATED ON (B)(6) 2024, THE RESULT WAS 0.3 AU/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170064 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 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)