BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 22845763 · Received August 19, 2025

    Report

    Report Number
    2024800-2025-00056
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    August 16, 2025
    Report Date
    August 19, 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

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED THE CUSTOMER WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. HOLOGIC DETERMINED THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT IS POTENTIAL SAMPLE MISHANDLING OR LOW TARGET SAMPLE. 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, CUSTOMER REPORTED A DISCREPANT RESULT USING APTIMA COMBO 2 (AC2) ASSAY MASTER LOT 921141 ON PANTHER PLUS INSTRUMENT. ON (B)(6) 2025, SAMPLE SID (B)(6) WAS TESTED USING AC2 (B)(4) ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) AND RETURNED A CT POSITIVE / GC POSITIVE RESULT. HOLOGIC TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT PER APTIMA COMBO 2 ASSAY PACKAGE INSERT, THE FIRST VALID RESULT FOR EACH ANALYTE IS THE RESULT THAT SHOULD BE REPORTED. CUSTOMER NOTED THEY WERE AWARE, BUT PER THEIR LABORATORY PROTOCOL, THEY ARE REQUIRED TO RETEST DUAL POSITIVE SAMPLES WITH RLU < 1900. ON (B)(6) 2025, THE SAME SAMPLE SID (B)(6) WAS RETESTED USING AC2 (B)(4) ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) AND RETURNED A CT NEGATIVE / GC NEGATIVE RESULT. CUSTOMER REPORTED OUT THE CT NEGATIVE / GC NEGATIVE RESULT TO THE PHYSICIAN/PATIENT. CUSTOMER WAS NOT AWARE OF ANY PATIENT TREATMENT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252914 APTIMA COMBO 2 ASSAY DNA-REAGENTS, NEISSERIA LSL HOLOGIC, INC. 921141 15420045505711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other