BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 21553354 · Received March 7, 2025

    Report

    Report Number
    2024800-2025-00009
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    February 4, 2025
    Report Date
    March 7, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LSL
    UDI-DI
    15420045514966
    PMA / PMN Number
    K111409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED ALL THREE WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. TS WAS UNABLE TO RULE OUT SAMPLE MISHANDLING OR LOW TARGET SAMPLES. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.

    Description of Event or Problem · 0

    ON FEBRUARY 10TH, 2025, CUSTOMER REPORTED A DISCREPANT RESULT USING APTIMA COMBO 2 ASSAY (ML 908987), WORKLIST 001320-20250205-09, ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6). CUSTOMER NOTED THE SAMPLE WAS INITIALLY RAN ON WORKLIST 001222-20250204-34 ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) USING THE SAME ASSAY AND OBTAINED A CT NEGATIVE AND GC EQUIVOCAL RESULT. CUSTOMER RETESTED THE SAMPLE ON WORKLIST 001320-20250205-09 (AS PREVIOUSLY MENTIONED) AND OBTAINED A CT POSITIVE AND GC NEGATIVE RESULT. CUSTOMER RETESTED THE SAMPLE FOR A SECOND TIME ON WORKLIST 011015-20250205-41 ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) USING THE SAME ASSAY AND OBTAINED A CT POSITIVE AND GC NEGATIVE RESULT. CUSTOMER NOTED THAT THEY REPORTED OUT THE INITIAL CT NEGATIVE GC EQUIVOCAL RESULT TO THE PATIENT. CUSTOMER WAS NOT PROVIDED ANY TREATMENT INFORMATION OF THE PATIENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214268 APTIMA COMBO 2 ASSAY DNA-REAGENTS, NEISSERIA LSL HOLOGIC, INC. 908987 15420045514966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other