BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 22840306 · Received August 19, 2025

    Report

    Report Number
    2024800-2025-00055
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 19, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC THOROUGHLY REVIEWED THE PANTHER INSTRUMENT LOGS AND CUSTOMER WORKLISTS AND NOTED NO INDICATION OF AN UNDERLYING HARDWARE ISSUE. HOLOGIC DETERMINED THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS A 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, A CUSTOMER REPORTED TO HOLOGIC A DISCREPANT RESULT ON PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6) USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY (MASTER LOT: 909954). THE CUSTOMER REPORTED THAT PER LAB IQA PROCEDURES, THEY SELECT RANDOM SAMPLES TO RETEST. ON (B)(6) 2025, SAMPLE (B)(6) INITIALLY RESULTED HPV NEGATIVE UNDER WORKLIST(B)(4). ON THE SAME DAY, THE SAME SAMPLE WAS RETESTED AS SAMPLE ID (B)(6) UNDER WORKLIST (B)(4) AND RESULTED HPV POSITIVE. ON (B)(6) 2025, THE CUSTOMER DECIDED TO RETEST THE SAMPLE (B)(6) FROM THE ORIGINAL THINPREP VIAL AND SAMPLE RESULTED POSITIVE UNDER WORKLIST (B)(4). THE CUSTOMER REPORTED THE FIRST VALID RESULT (NEGATIVE RESULT FROM (B)(6) 2025). 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
    251117 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 909954 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other