BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 25128789 · Received May 8, 2026

    Report

    Report Number
    2024800-2026-00021
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 8, 2026
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LSL
    UDI-DI
    15420045505711
    PMA / PMN Number
    K111409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC REVIEWED THE PANTHER LOG FILES AND WORKLISTS AND NOTED THERE WERE NO INDICATIONS OF HARDWARE OR REAGENT PREPARATION ISSUES THAT AFFECTED RESULTS. THE DISCREPANT RESULT APPEARED TO BE SAMPLE RELATED, POSSIBLY DUE TO LOW TARGET CONCENTRATION OR SAMPLE MISHANDLING. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

    Description of Event or Problem · 0

    ON APRIL 29, 2026, CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS WHILE PERFORMING A LOT-TO-LOT VERIFICATION FOR SAMPLE ID (SID): (B)(6) WHILE USING THE APTIMA COMBO 2 ASSAY ON THEIR PANTHER INSTRUMENT WITH SERIAL NUMBER (SN): (B)(6). ON (B)(6) 2026, SID: (B)(6) WAS INITIALLY TESTED ON WORKLIST (WL) (B)(4) (ML 924056) ON PANTHER INSTRUMENT (SN: (B)(6) AND RESULTED CT NEGATIVE/GC POSITIVE. ON (B)(6) 2026, CUSTOMER RETESTED SID: (B)(6) ON WORKLIST (B)(4) (ML 926168) ON PANTHER INSTRUMENT (SN: (B)(6) AND THE SAMPLE RESULTED CT POSITIVE/GC POSITIVE. ACCORDING TO THE CUSTOMER, THE FIRST VALID RESULT WAS REPORTED TO THE PATIENT. 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
    22839 APTIMA COMBO 2 ASSAY DNA-REAGENTS, NEISSERIA LSL HOLOGIC, INC. 924056, 926168 15420045505711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other