BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 21289082 · Received January 31, 2025

    Report

    Report Number
    2024800-2025-00006
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    January 14, 2025
    Report Date
    January 31, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED BOTH WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. TS NOTED THAT THE SAMPLES WERE EITHER MISHANDLED OR WERE TRUE 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 SITUATION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, CUSTOMER REPORTED A DISCREPANT RESULT USING APTIMA HPV SCREENING ASSAY (ML 905627), WORKLIST: (B)(4), ON PANTHER PLUS INSTRUMENT SERIAL NUMBER: (B)(6). CUSTOMER NOTED THE SAMPLE WAS RAN IN DUPLICATE ON THE SAME WORKLIST AND PRODUCED BOTH A NEGATIVE AND POSITIVE RESULT. CUSTOMER RETESTED THE SAME SAMPLE USING WORKLIST: (B)(4) ON PANTHER INSTRUMENT SERIAL NUMBER: (B)(6) AND OBTAINED A NEGATIVE RESULT. CUSTOMER NOTED THAT THEY WOULD REPORT THE NEGATIVE RESULT TO THE PATIENT. 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
    495691 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 905627 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other