BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 22119528 · Received May 30, 2025

    Report

    Report Number
    2024800-2025-00027
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    May 7, 2025
    Report Date
    May 30, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED AVAILABLE LOGS FOR BOTH INITIAL TEST WORKLIST (B)(4) AND RETEST WORKLIST (B)(4) AND NOTED NO HARDWARE, SOFTWARE OR CONTAMINATION ISSUES. TS INDICATED THAT THE ISSUE WAS MOST LIKELY DUE TO LOW TARGET OR SAMPLE MISHANDLING. HOLOGIC COMPLETED A RISK ASSESSMENT. THERE IS NO PRODUCT IMPACT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON PANTHER PLUS INSTRUMENT SN# (B)(6). SAMPLE IDS # (B)(6) WERE PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE IN HPV WORKLIST # (B)(4). PER CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVES CONTAINING RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THE SAMPLES WITH S/CO<5 WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID # (B)(6) RESULTED HPV NEGATIVE, AND THIS RESULT WAS REPORTED OUT. SAMPLE IDS # (B)(6) WERE NOT RETESTED AS THESE SAMPLES RESULTED HPV POSITIVE WITH AN S/CO > 5. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844370 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 908328 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other