BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 24335218 · Received February 13, 2026

    Report

    Report Number
    2024800-2026-00005
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    January 19, 2026
    Report Date
    February 13, 2026
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TS REVIEWED THE SYSTEM LOGFILES PROVIDED BY CUSTOMER. REVIEW OF THE LOGS DID NOT REVEAL ANY HARDWARE OR INSTRUMENT ISSUES THAT CONTRIBUTED TO THESE DISCREPANT RESULTS. BASED ON THE AVAILABLE DATA, THE MOST LIKELY CAUSE FOR THE DISCREPANT RESULTS ACROSS REPEAT TESTING OF THESE SAMPLES IS A LOW TARGET CONCENTRATION NEAR THE LIMIT OF DETECTION.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A CUSTOMER IN GERMANY REPORTED TO HOLOGIC THAT DISCREPANT RESULTS WERE GENERATED WHILST USING THE APTIMA HUMAN PAPILLOMAVIRUS (HPV) ASSAY (ML 913266) WITH PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6)). THE INCIDENT WAS RECORDED UNDER HOLOGIC REFERENCE NUMBER (B)(4). ON (B)(6) 2026, SAMPLE ID (B)(6) WERE TESTED ON PANTHER WORKLIST ID (B)(4) AND GENERATED AN APTIMA HUMAN PAPILLOMAVIRUS (HPV) ASSAY (ML 913266) NEGATIVE RESULT. THE SAME SAMPLES ((B)(6)) WERE RETESTED ON (B)(6) 2026 ON THE SAME PANTHER INSTRUMENT (WORKLIST ID (B)(4)) AND GENERATED AN APTIMA HUMAN PAPILLOMAVIRUS (HPV) ASSAY POSITIVE RESULT. ON (B)(6) 2026, THE SAME SAMPLES ((B)(6)) WERE RETESTED AGAIN ON THE SAME PANTHER INSTRUMENT (WORKLIST ID (B)(4)) AND GENERATED AN APTIMA HUMAN PAPILLOMAVIRUS (HPV) ASSAY NEGATIVE RESULT. THE CUSTOMER REPORTED OUT THE FIRST VALID RESULT FOR SAMPLE ID (B)(6), WHICH WAS THE AHPV NEGATIVE RESULT FROM THE INITIAL TEST ON (B)(6) 2026. 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
    391447 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 913266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown