BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV 16 18/45 GENOTYPE ASSAY

    MDR report key: 24308439 · Received February 10, 2026

    Report

    Report Number
    2024800-2026-00003
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 10, 2026
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OYB
    UDI-DI
    15420045500112
    PMA / PMN Number
    P120007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER ORIGINALLY REPORTED INVALID SAMPLES RESULTS ON APTIMA HPV 16 18/45 GENOTYPE (AHPV-GT) ASSAY WORKLIST (WL) (B)(4). HOLOGIC REVIEWED PANTHER LOGS AND WORKLISTS PROVIDED AND NOTED INDICATIONS OF POTENTIAL REAGENT KIT PREPARATION ISSUES THAT MAY HAVE IMPACTED VALID RESULTS ON THIS WORKLIST. HOLOGIC RECOMMENDED CUSTOMER TO REPEAT SAMPLES FROM WL (B)(4) WITH A NEWLY PREPARED REAGENT KIT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2026, CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT RESULTS ON THREE SAMPLES IDS (SIDS) (B)(6) WHILE RUNNING THE APTIMA HPV 16 18/45 GENOTYPE (AHPV-GT) ASSAY (ML 920131) ON THEIR PANTHER PLUS INSTRUMENT (SN: (B)(6). ON (B)(6) 2026, CUSTOMER INITIALLY TESTED ALL THREE SAMPLES ON AHPV-GT WORKLIST (WL) (B)(4) AND RECEIVED VALID HPV 16 NEGATIVE AND HPV 18/45 NEGATIVE RESULTS FOR THESE SAMPLES. DUE TO POTENTIAL REAGENT KIT PREPARATION ISSUES WITH THE INITIAL WORKLIST, CUSTOMER LATER RETESTED ALL SAMPLES FROM WL (B)(4) USING THE SAME SAMPLE TUBE ON (B)(6) 2026, WITH WL (B)(4) USING A NEW REAGENT KIT ON THE SAME PANTHER INSTRUMENT. SIDS (B)(6) RESULTED HPV 16 POSITIVE AND HPV 18/45 NEGATIVE UPON RETEST, WHILE SID (B)(6) RESULTED HPV 16 NEGATIVE AND HPV 18/45 POSITIVE ON RETEST. IN ADDITION, CUSTOMER ALSO TESTED NEW ALIQUOTS OF THESE SAMPLES IN WL (B)(4). NEW ALIQUOTS OF SIDS (B)(6) RESULTED HPV 16 POSITIVE AND HPV 18/45 NEGATIVE AND NEW ALIQUOT OF SID (B)(6) RESULTED HPV 16 NEGATIVE AND HPV 18/45 POSITIVE. CUSTOMER DID NOT CONFIRM WHICH SAMPLE RESULTS WERE REPORTED OUT OR AMENDED NOR DID CUSTOMER PROVIDE ANY INFORMATION ON PATIENTS OR PATIENT TREATMENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363277 APTIMA HPV 16 18/45 GENOTYPE ASSAY KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS OYB HOLOGIC, INC. 920131 15420045500112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other