BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 24732950 · Received March 30, 2026

    Report

    Report Number
    2024800-2026-00016
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 17, 2026
    Report Date
    March 30, 2026
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC REVIEWED THE PANTHER SYSTEM LOGS AND OBSERVED NO SIGNS OF HARDWARE FAILURE OR REAGENT PREPARATION ISSUES FOR WORKLIST ID: (B)(4). THE ISSUE APPEARED TO BE SAMPLE RELATED, MOST LIKELY DUE TO A LOW TARGET CONCENTRATION OR SAMPLE MISHANDLING. HOLOGIC HAS NOT LEARNED OF ANY PATIENT TREATMENT OR ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A CUSTOMER IN CANADA REPORTED TO HOLOGIC THAT THEY HAD DISCREPANT RESULTS FOR 2 ALIQUOTS OF THE SAME SOURCE SAMPLE TESTED IN TRIPLICATE WITH THE APTIMA HPV ASSAY KIT RUN ON THE PANTHER PLUS INSTRUMENT SN: (B)(6). ON (B)(6) 2026, WHILE PERFORMING A NEW ASSAY KIT LOT VALIDATION, SAMPLE ID: (B)(6) WAS TESTED USING HPV ASSAY KIT MASTER LOT (ML) 921025 AND INITIALLY RESULTED HPV POSITIVE, THEN POSITIVE AND NEGATIVE UPON RETESTING IN WORKLIST ID: (B)(4). SAMPLE ID: (B)(6) WAS TESTED USING HPV ASSAY KIT ML 927271 AND INITIALLY RESULTED HPV POSITIVE, THEN NEGATIVE AND NEGATIVE UPON RETESTING IN WORKLIST ID: (B)(4). THE CUSTOMER EXPECTED THE RESULT TO BE NEGATIVE BASED ON PREVIOUS TESTING. LOGS FOR PREVIOUS TESTS WERE NOT PROVIDED, AND IT IS NOT CLEAR WHETHER THESE PREVIOUS RUNS WERE USING THE SAME SAMPLE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784560 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 927271, 921025 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other