BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 22925711 · Received August 29, 2025

    Report

    Report Number
    2024800-2025-00059
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    August 12, 2025
    Report Date
    August 29, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED ALL OF CUSTOMER WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. HOLOGIC DETERMINED THE MOST LIKELY CAUSE OF THE DISCREPANT HPV 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, A CUSTOMER REPORTED TO HOLOGIC A DISCREPANT RESULT USING APTIMA HPV ASSAY MASTER LOT 915392 WHEN TESTING A SAMPLE ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6). ON (B)(6) 2025, SAMPLE SID (B)(6) WAS TESTED ON HPV (B)(4) AND RESULTED HPV NEGATIVE WITH AN S/CO VALUE OF 0.00. CUSTOMER REPORTED THIS RESULT TO THE PHYSICIAN/PATIENT. CUSTOMER NOTED THAT THIS SAMPLE WAS ACCIDENTALLY LEFT ON THE INSTRUMENT AND RUN AGAIN ON THE SAME WORKLIST THE NEXT DAY. ON (B)(6) 2025, SAMPLE SID (B)(6) RESULTED HPV POSITIVE WITH AN S/CO VALUE OF 5.26. ON (B)(6) 2025, THE SAME SAMPLE WAS RETESTED ON HPV (B)(4) AND RESULTED HPV POSITIVE AGAIN WITH AN S/CO VALUE OF 5.97. CUSTOMER NOTED THAT ALL 3 TESTS WERE PERFORMED WITH THE SAME SAMPLE TUBE. THE RESULT WAS AMENDED TO INDETERMINATE AND CUSTOMER REQUESTED FOR A NEW SAMPLE TO BE RECOLLECTED. 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
    2164482 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 915392 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other