BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 22547284 · Received July 18, 2025

    Report

    Report Number
    2024800-2025-00045
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 23, 2025
    Report Date
    July 18, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED ALL OF WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. SUSPECTED POTENTIAL SAMPLE MISHANDLING OR LOW TARGET SAMPLES. TS INFORMED THE CUSTOMER THAT USING PATIENT SAMPLES FOR VERIFICATION RUNS IS NOT RECOMMENDED AND THE CUSTOMER UNDERSTOOD. 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 RECEIVING DISCREPANT RESULTS USING APTIMA HPV ASSAY (MASTER LOT 916336) ON PANTHER PLUS INSTRUMENT (SERIAL NUMBER (B)(6). ON (B)(6) 2025, FOLLOWING SERVICE ON THEIR PANTHER PLUS INSTRUMENT (SN (B)(6), CUSTOMER DECIDED TO PERFORM A VERIFICATION RUN USING 10 SAMPLES THAT PREVIOUSLY RESULTED HPV POSITIVE AND 10 SAMPLES THAT PREVIOUSLY RESULTED HPV NEGATIVE. TWO OF THE INITIAL HPV POSITIVE SAMPLES (SAMPLE IDS (B)(6) RESULTED AS HPV NEGATIVE ON HPV. (B)(6). ON (B)(6) 2025, THE CUSTOMER OPTED TO PERFORM ANOTHER RETEST ON THESE SAMPLE IDS: (B)(6), ALONGSIDE AN ADDITIONAL 5 SAMPLE IDS THAT INITIALLY TESTED HPV POSITIVE AND 5 SAMPLE IDS THAT INITIALLY TESTED HPV NEGATIVE. SAMPLE ID (B)(6) RESULTED HPV NEGATIVE, WHILE SAMPLE ID (B)(6) RESULTED HPV POSITIVE ON HPV (B)(6). OF THE ADDITIONAL 5 HPV POSITIVE SAMPLES RETESTED, 2 (SAMPLE IDS: (B)(6) PRODUCED HPV NEGATIVE RESULTS. FOR ALL THESE SAMPLES, THE INITIAL POSITIVE RESULTS WERE REPORTED AND THE RETEST RESULTS WERE NOT REPORTED. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195753 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 916336 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other