BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 21952202 · Received May 2, 2025

    Report

    Report Number
    2024800-2025-00015
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    April 7, 2025
    Report Date
    May 2, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LSL
    UDI-DI
    15420045505711
    PMA / PMN Number
    K111409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT THOROUGHLY REVIEWED CUSTOMER LOGS AND OBSERVED THAT CONTROLS PERFORMED AS EXPECTED AND THAT NO HARDWARE ISSUES WERE NOTICED. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC DETERMINED THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT IS LOW GC TARGET IN THE SAMPLE OR SAMPLE MISHANDLING. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT. H3 OTHER TEXT : OTHER

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC A POTENTIAL FALSE NEGATIVE NEISSERIA GONORRHOEAE (GC) RESULT WHILE USING THE APTIMA COMBO 2 ASSAY (LOT NUMBER: 905100) ON THE PANTHER INSTRUMENT (B)(6). (B)(6) INITIALLY TESTED CT NEGATIVE AND GC POSITIVE, BUT GENERATED CT NEGATIVE AND GC NEGATIVE RESULTS UPON RETEST IN THE SAME AC2 (B)(4). CUSTOMER CONFIRMED THE RETEST GC NEGATIVE RESULT WAS REPORTED OUT TO THE CLINICIAN. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191708 APTIMA COMBO 2 ASSAY DNA-REAGENTS, NEISSERIA LSL HOLOGIC, INC. 905100 15420045505711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other