BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 24575801 · Received March 11, 2026

    Report

    Report Number
    2024800-2026-00011
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 11, 2026
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TS REVIEWED THE SYSTEM LOG FILES PROVIDED BY THE CUSTOMER, AND PRELIMINARY ANALYSIS INDICATES THAT THE MOST LIKELY EXPLANATION FOR THE DISCREPANT RESULT IS EITHER A LOW TARGET CONCENTRATION IN THE SAMPLE NEAR THE LIMIT OF DETECTION OR THAT THE SAMPLE WAS MISHANDLED/CONTAMINATED. REVIEW OF THE LOGS AND KINETIC CURVE DATA DID NOT REVEAL ANY HARDWARE OR INSTRUMENT ISSUES THAT CONTRIBUTED TO THE DISCREPANT RESULT.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A CUSTOMER IN FRANCE REPORTED TO HOLOGIC THAT DISCREPANT RESULTS WERE GENERATED WHILST USING THE APTIMA HUMAN PAPILLOMAVIRUS (HPV) ASSAY, MASTER LOT (ML) 922916 WITH PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6). THE INCIDENT WAS RECORDED UNDER HOLOGIC REFERENCE NUMBER (B)(4). ON 20 JANUARY 2026, SAMPLE ID (B)(6) WAS TESTED ON HPV WORKLIST ID (B)(6) AND GENERATED AN HPV NEGATIVE RESULT. THE SAME SAMPLE (ID (B)(6) WAS RETESTED ON (B)(6) 2026 ON THE PANTHER INSTRUMENT (WORKLIST ID (B)(4) AND GENERATED AN HPV POSITIVE RESULT. THE CUSTOMER DID NOT REPORT ANY RESULTS TO THE PATIENT PRIOR TO RETESTING. NO INFORMATION REGARDING PATIENT TREATMENT IS AVAILABLE AT THIS TIME. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOME RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222788 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 922916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other