BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 19952879 · Received August 9, 2024

    Report

    Report Number
    2024800-2024-00010
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 9, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC REVIEWED LOGS AND KINETIC CURVES PROVIDED BY THE CUSTOMER. HOLOGIC OBSERVED SIGNS OF POSITIVE AND NEGATIVE CONTAMINATION. ON JULY 23, 2024, A HOLOGIC MOLECULAR APPLICATIONS SPECIALISTS (MAS) VISITED THE CUSTOMER SITE AND COLLECTED ENVIRONMENTAL SWABS. THE SWABS WERE TESTED AT HOLOGIC AND INDICATED INSTRUMENT AND LAB CONTAMINATION. AFTER MULTIPLE ROUNDS OF CLEANING AT THE CUSTOMER SITE, MAS CONFIRMED THAT THE CONTAMINATION WAS CLEARED, AND THE INSTRUMENT WAS RELEASED TO THE CUSTOMER. HOLOGIC COMPLETED A RISK ASSESSMENT. THERE IS NO PRODUCT IMPACT. THE INCONSISTENT RESULTS WERE DUE TO CONTAMINATION FOUND AND CONFIRMED AT CUSTOMER SITE AND POTENTIAL SAMPLE MISHANDLING. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Description of Event or Problem · 0

    ON JULY 10, 2024, ONE CUSTOMER REPORTED TO HOLOGIC THAT THEY HAD THREE DISCREPANT RESULTS USING THE APTIMA HPV ASSAY (LOT 895916) ON THE PANTHER INSTRUMENT. THE CUSTOMER HAD BEEN USING HPV NEGATIVE CALIBRATORS AS AN EXTERNAL QUALITY CONTROL (EQC), THAT RESULTED POSITIVE WHILE USING MASTER LOT (ML) 895916. DUE TO THE INITIAL EQC RESULT, THE CUSTOMER DECIDED TO RETEST ALL SAMPLES USING THE SAME ALIQUOT AND RECEIVED THREE NEGATIVE RESULTS UPON RETEST. HOLOGIC TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT HPV CALIBRATORS ARE SINGLE-USE TUBES AND ARE NOT TO BE REUSED AS AN EQC. THE CUSTOMER DECIDED TO WITHHOLD THE RESULTS DUE TO INITIAL EQC RESULT, AND REPORTED THE NEGATIVE RESULTS TO THE PATIENTS ACCORDINGLY. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493431 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 895916 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other