BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 22028618 · Received May 15, 2025

    Report

    Report Number
    2024800-2025-00018
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    April 25, 2025
    Report Date
    May 15, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. OTHER.

    Description of Event or Problem · 0

    ON (B)(6) 2025, CUSTOMER REPORTED 7 DISCREPANT RESULTS USING APTIMA HPV ASSAY ON PANTHER FUSION INSTRUMENTS. ALL 7 SAMPLES WERE INITIALLY RUN IN HPV WORKLIST 003175-20250423-02 USING APTIMA HPV ASSAY (ML: 911442) ON PANTHER FUSION INSTRUMENT (SN: (B)(6). FOUR SAMPLES RESULTED HPV POSITIVE (SAMPLE ID# (B)(6), WHILE THE OTHER 3 SAMPLES RESULTED HPV NEGATIVE (SAMPLE ID# (B)(6). CUSTOMER RETESTED THE SAMPLES IN HPV WORKLIST 002809-20250425 USING APTIMA HPV ASSAY (ML: 908328) ON PANTHER INSTRUMENT (SN:(B)(6) AND OBTAINED DISCREPANT RESULTS FOR EACH SAMPLE: THE 4 INITIAL HPV POSITIVE SAMPLES RESULTED HPV NEGATIVE AND THE 3 INITIAL HPV NEGATIVE SAMPLES RESULTED HPV POSITIVE. CUSTOMER THEN RETESTED THE SAME SAMPLES AGAIN IN HPV WORKLIST 002640-20250427-11 USING APTIMA HPV ASSAY (ML: 911623) ON PANTHER FUSION INSTRUMENT (SN: (B)(6) AND OBTAINED 2 DISCREPANT RESULTS COMPARED TO THE RETESTED RESULTS: SAMPLE ID# (B)(6) RETESTED HPV POSITIVE AND SAMPLE ID# (B)(6) RETESTED HPV NEGATIVE. CUSTOMER DECIDED TO REPORT 2 OF THE SAMPLES (SAMPLE ID# (B)(6), AS HPV POSITIVE AND THE 5 OTHER SAMPLES AS HPV NEGATIVE TO PHYSICIANS/PATIENTS. 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
    1896890 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 908328, 911442, & 911623 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other