BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 22116412 · Received May 30, 2025

    Report

    Report Number
    2024800-2025-00029
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    May 17, 2025
    Report Date
    May 30, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LSL
    UDI-DI
    15420045505711
    PMA / PMN Number
    K111409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED ALL OF WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. SUSPECTED POTENTIAL 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 ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING APTIMA COMBO 2 ASSAY (AC2) MASTER LOT 915709 ON PANTHER PLUS INSTRUMENT. SAMPLE ID# (B)(6) INITIALLY RESULTED CT POSITIVE & GC POSITIVE ON AC2 (B)(4) ON PANTHER PLUS INSTRUMENT SN (B)(6). THE SAME SAMPLE WAS RETESTED AND RESULTED CT NEGATIVE & GC NEGATIVE ON AC2 (B)(4) ON PANTHER PLUS INSTRUMENT SN (B)(6). CUSTOMER REPORTED THE RETESTED CT NEGATIVE & GC NEGATIVE RESULT TO THE PATIENT. PER APTIMA COMBO 2 ASSAY PACKAGE INSERT ¿THE FIRST VALID RESULT FOR EACH ANALYTE IS THE RESULT THAT SHOULD BE REPORTED¿. CUSTOMER WAS INFORMED THAT NOT REPORTING OUT THE FIRST VALID RESULT IS CONSIDERED OFF-LABEL. CUSTOMER NOTED THAT THEY ARE AWARE BUT PER THEIR LAB SOP, ALL DUAL POSITIVE SAMPLES WITH RELATIVE LIGHT VALUES (RLUS) <1900 ARE TO BE REPEATED AND IF THE RETEST IS NEGATIVE, THEY REPORT OUT THE NEGATIVE RESULT. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642290 APTIMA COMBO 2 ASSAY DNA-REAGENTS, NEISSERIA LSL HOLOGIC, INC. 915709 15420045505711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other