BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV SCREENING ASSAY

    MDR report key: 20458043 · Received October 15, 2024

    Report

    Report Number
    2024800-2024-00021
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 16, 2024
    Report Date
    October 15, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 THAT THE ISSUE IS SAMPLE-RELATED DUE TO LOW-TARGET OR CONTAMINATION DURING HANDLING. HOLOGIC RECOMMENDED THAT THE CUSTOMER PREPARE FRESH BLEACH, PERFORM MONTHLY MAINTENANCE, CLEAN PREPARATION AREAS/TOUCH POINTS, CLEAN THE SAMPLE SHIELD, AND CHANGE GLOVES FREQUENTLY. AFTER PERFORMING MONTHLY MAINTENANCE, THE CUSTOMER HAD A SUCCESSFUL RUN WITH BLANKS THAT TESTED NEGATIVE AS EXPECTED. HOLOGIC COMPLETED A RISK ASSESSMENT. THERE IS NO PRODUCT IMPACT. THE INCONSISTENT RESULTS WERE DUE TO LOW TARGET OR POTENTIAL SAMPLE MISHANDLING. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED TWO DISCREPANT RESULTS WHEN USING THE APTIMA HPV ASSAY (ML 900928) ON THE PANTHER PLUS INSTRUMENT. AFTER THEIR LOT-TO-LOT VALIDATION DID NOT PRODUCE THE EXPECTED RESULTS, THE CUSTOMER DECIDED TO RETEST THE TWO SAMPLES USING THE SAME ALIQUOTS. SAMPLE ID# (B)(6) INITIALLY TESTED POSITIVE AND NEGATIVE UPON RETEST. ANOTHER SAMPLE, SAMPLE ID# (B)(6), INITIALLY TESTED NEGATIVE AND POSITIVE UPON RETEST. THE CUSTOMER REPORTED THE NEGATIVE RESULTS FOR BOTH SAMPLES. IT IS UNCLEAR IF RESULTS WERE AMENDED. THE CUSTOMER PROVIDED NO PATIENT TREATMENT INFORMATION. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558668 APTIMA HPV SCREENING ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 900928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other