BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 21987815 · Received May 8, 2025

    Report

    Report Number
    2024800-2025-00017
    Event Type
    Injury
    Date Received
    May 8, 2025
    Date of Event
    April 10, 2025
    Report Date
    May 8, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 APRIL 15TH, 2025, CUSTOMER REPORTED 8 DISCREPANT RESULTS USING APTIMA HPV ASSAY ON PANTHER PLUS INSTRUMENT. ALL 8 SAMPLES WERE INITIALLY RAN ON HPV WORKLIST (B)(4) USING APTIMA HPV ASSAY (ML: 912703) ON PANTHER PLUS INSTRUMENT (SN: (B)(6)), AND 3 SAMPLES RESULTED HPV POSITIVE WHILE THE OTHER 5 SAMPLES RESULTED HPV NEGATIVE. CUSTOMER NOTED THAT THE INITIAL RESULTS WERE REPORTED TO PATIENTS. CUSTOMER RETESTED THE ORIGINAL 8 SAMPLES ACROSS 4 DIFFERENT HPV WORKLISTS (B)(4) ON PANTHER PLUS INSTRUMENTS (SNS: (B)(6)) AND OBTAINED FLIPPED DISCREPANT RESULTS FOR EACH SAMPLE (THE 5 INITIALLY HPV NEGATIVE SAMPLES RESULTED HPV POSITIVE WHILE THE 3 INITIALLY HPV POSITIVE SAMPLES RESULTED HPV NEGATIVE). CUSTOMER AMENDED THE 5 SAMPLES THAT INITIALLY RESULTED HPV NEGATIVE TO HPV POSITIVE. CUSTOMER DID NOT PROVIDE ANY PATIENT TREATMENT INFORMATION. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761088 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 912703 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other