BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 23866139 · Received December 22, 2025

    Report

    Report Number
    2024800-2025-00077
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    December 8, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC REVIEWED THE PANTHER LOGS AND WORKLISTS AND NOTED THERE WERE NO INDICATIONS OF INSTRUMENT OR REAGENT PREPARATION ISSUES; THE MOST LIKELY CAUSE OF THE DISCREPANT RESULTS WAS LOW TARGET IN THE SAMPLES OR SAMPLE MISHANDLING/CONTAMINATION. 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 DISCREPANT RESULTS FOR SAMPLE ID¿S (SID) (B)(6) WHILE USING THE APTIMA HPV ASSAY ML 919387 ON THEIR PANTHER PLUS INSTRUMENT (SN (B)(6)). ON (B)(6) 2025, THE CUSTOMER INITIALLY TESTED THESE SID ON WORKLIST (WL) (B)(4) AND RECEIVED A POSITIVE RESULT FOR SID (B)(6), AND A NEGATIVE RESULT FOR SID (B)(6). PER CUSTOMER LAB POLICY, A POSITIVE RESULT MUST BE MANUALLY APPROVED, AND A NEGATIVE RESULT GETS REPORTED AUTOMATICALLY. ON (B)(6) 2025, THE CUSTOMER RETESTED THESE SAMPLES IN WL (B)(4) ON A DIFFERENT PANTHER INSTRUMENT (SN (B)(6)) AND RECEIVED DISCREPANT RESULTS: SID (B)(6) AND SID (B)(6) TESTED NEGATIVE AND SID (B)(6) TESTED POSITIVE. CUSTOMER CONFIRMED THE HPV NEGATIVE RESULTS WERE REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318347 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 919387 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown