BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 19244080 · Received May 3, 2024

    Report

    Report Number
    2024800-2024-00009
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 4, 2024
    Report Date
    May 3, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    UDI-DI
    15420045500051
    PMA / PMN Number
    P100042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC APPLICATION SPECIALIST (PAS) REVIEWED THE LOGS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. PAS NOTED THAT LOW TARGET SAMPLES COULD BE THE CAUSE OF THE DISCREPANT RESULTS. HOLOGIC TECHNICAL SUPPORT (TS) PROVIDED THE CUSTOMER WITH THE LOG REVIEW AND THE CUSTOMER DID NOT EXPRESS FURTHER CONCERN. CUSTOMER MENTIONED THAT PER THEIR LAB PROTOCOL, IF A SAMPLE INITIALLY RESULTS AS POSITIVE AND THEN REPEATS NEGATIVE TWICE, THEY WILL REPORT OUT NEGATIVE. NO FURTHER ISSUES WERE REPORTED. THE APTIMA HPV (AHPV) PACKAGE INSERT STATES THAT DETECTION OF HIGH-RISK HPV MRNA IS DEPENDENT ON THE NUMBER OF COPIES PRESENT IN THE SPECIMEN AND MAY BE AFFECTED BY SPECIMEN COLLECTION METHODS, PATIENT FACTORS, STAGE OF INFECTION, STORAGE, SPECIMEN PROCESSING AND THE PRESENCE OF INTERFERING SUBSTANCES. IN ADDITION, THE PACKAGE INSERT STATES THAT RESULTS FROM THE APTIMA HPV ASSAY SHOULD BE USED IN CONJUNCTION WITH CLINICAL INFORMATION DERIVED FROM OTHER DIAGNOSTIC AND SCREENING TESTS, PHYSICAL EXAMINATIONS, AND FULL MEDICAL HISTORY IN ACCORDANCE WITH APPROPRIATE PATIENT MANAGEMENT PROCEDURES.

    Description of Event or Problem · 0

    ON (B)(6) 2024, CUSTOMER REPORTED TO HOLOGIC THAT TWO DISCREPANT HPV SAMPLES WERE RUN ON PANTHER FUSION PLUS INSTRUMENT USING THE APTIMA HPV ASSAY. BOTH SAMPLES WERE INADVERTENTLY TESTED IN DUPLICATE IN THE SAME WORKLIST. THE SAMPLES INITIALLY TESTED HPV POSITIVE BUT THE SECOND REPLICATE FOR BOTH SAMPLES WERE HPV NEGATIVE. CUSTOMER ALSO NOTED THAT A SECOND RUN WAS PERFORMED, WHICH PRODUCED THE HPV NEGATIVE RESULTS; HOWEVER, LOGS FOR THE SECOND RUN WERE NOT PROVIDED. CUSTOMER DECIDED TO REPORT OUT THE NEGATIVE RESULTS. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION FROM THE CLINICIAN AND/OR PATIENT REGARDING TREATMENT OR CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591677 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 889994 15420045500051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other