BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 22080982 · Received May 23, 2025

    Report

    Report Number
    2024800-2025-00022
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    March 5, 2025
    Report Date
    May 23, 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 ALL OF WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. SUSPECTED POTENTIAL SAMPLE MISHANDLING OR LOW TARGET SAMPLES. 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 THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON PANTHER PLUS INSTRUMENT SN (B)(6). SAMPLE ID (B)(6) WERE BOTH PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE ON (B)(4). PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVE RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THESE SAMPLES WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID (B)(6) BOTH RESULTED HPV NEGATIVE ON (B)(4). 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
    2261174 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 908328 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other