BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 23609173 · Received November 20, 2025

    Report

    Report Number
    2024800-2025-00073
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    November 12, 2025
    Report Date
    November 20, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LSL
    PMA / PMN Number
    K111409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC REVIEWED THE PANTHER LOGS AND WORKLISTS AND NOTED THERE WERE NO INDICATIONS OF HARDWARE OR REAGENT PREPARATION ISSUES THAT AFFECTED RESULTS. WHILE THE CAUSE OF THE OBSERVED DISCREPANT RESULTS IS UNKNOWN, IT IS POSSIBLE THE STRING OF NINE GC POSITIVE RESULTS OCCURRED DUE TO AN INTERACTION WITH AN INCORRECTLY SEATED SAMPLE SHIELD. HOLOGIC REVIEW DID NOT SHOW INDICATION OF INSTRUMENT CONTAMINATION. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT RESULTS ON NINE SAMPLES WHILE RUNNING THE APTIMA COMBO 2 (AC2) ASSAY (ML 914754) ON THEIR PANTHER INSTRUMENT (SN (B)(6). ON (B)(6) 2025, CUSTOMER INITIALLY TESTED ALL NINE SAMPLES ON AC2 WORKLIST (WL) (B)(4) AND RECEIVED CHLAMYDIA TRACHOMATIS (CT) NEGATIVE / NEISSERIA GONORRHOEAE (GC) POSITIVE RESULTS ON SEVEN OF THE NINE SAMPLE IDS (SIDS) (B)(6). CUSTOMER RECEIVED CT POSITIVE / GC POSITIVE RESULTS ON THE OTHER TWO SIDS (B)(6). CUSTOMER INSPECTED THE SAMPLE SHIELD AFTER THE INITIAL TESTING AND REPORTED A FAINT DRIED SMEAR ON THE SHIELD SURFACE, ADJACENT TO WHERE THE AFFECTED SAMPLES WERE LOADED. CUSTOMER REPLACED THE SAMPLE SHIELD AND RETESTED EIGHT OF THE NINE SAMPLES (ALL EXCEPT SID (B)(6) ON THE SAME WL AND RECEIVED CT NEGATIVE / GC NEGATIVE RESULTS ON SIDS (B)(6), AND CT POSITIVE / GC NEGATIVE RESULTS ON SIDS (B)(6). ON (B)(6) 2025, CUSTOMER PERFORMED AN ADDITIONAL RETEST OF ALL NINE SAMPLES ON (B)(4) ON A DIFFERENT PANTHER INSTRUMENT (SN (B)(6) AND RECEIVED CT POSITIVE / GC POSITIVE RESULT FOR SID (B)(6), CT EQUIVOCAL / GC NEGATIVE RESULT FOR SID (B)(6), CT POSITIVE / GC NEGATIVE RESULTS ON SID (B)(6), AND CT NEGATIVE / GC NEGATIVE RESULTS ON THE OTHER SIX SAMPLES. CUSTOMER CONFIRMED NONE OF THE RESULTS FROM THE INITIAL (B)(4) WERE REPORTED OUT, AND THEY REQUESTED SAMPLE RECOLLECTION OF ALL SAMPLES. CUSTOMER DID NOT PROVIDE ANY INFORMATION ON THE PATIENT 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
    2661681 APTIMA COMBO 2 ASSAY DNA-REAGENTS, NEISSERIA LSL HOLOGIC, INC. 914754

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other