BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 22302360 · Received June 20, 2025

    Report

    Report Number
    2024800-2025-00037
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    June 16, 2025
    Report Date
    June 20, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LSL
    UDI-DI
    15420045505711
    PMA / PMN Number
    K111409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT. HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED ALL OF THE WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. TS SUSPECTED POTENTIAL SAMPLE MISHANDLING OR LOW TARGET SAMPLES. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING APTIMA COMBO 2 ASSAY (AC2) ON PANTHER PLUS INSTRUMENT. ON (B)(6) 2025, SAMPLE ID # (B)(6) WAS INITIALLY TESTED IN AC2 WL-010146-20250614-14 USING AC2 MASTER LOT 917189 ON PANTHER PLUS INSTRUMENT SN (B)(6) AND RESULTED CT POSITIVE & GC POSITIVE. THE SAME SAMPLE WAS RETESTED ON(B)(6) 2025 IN AC2 WL-010823-20250616-19 USING AC2 MASTER LOT 917920 ON PANTHER PLUS INSTRUMENT SN (B)(6) AND RESULTED CT NEGATIVE & GC NEGATIVE. CUSTOMER REPORTED THE RETESTED CT NEGATIVE & GC NEGATIVE RESULT TO THE PHYSICIAN/PATIENT. PER APTIMA COMBO 2 ASSAY PACKAGE INSERT ¿THE FIRST VALID RESULT FOR EACH ANALYTE IS THE RESULT THAT SHOULD BE REPORTED¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033564 APTIMA COMBO 2 ASSAY DNA-REAGENTS, NEISSERIA LSL HOLOGIC, INC. 917189 & 917920 15420045505711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other