BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 20855259 · Received December 5, 2024

    Report

    Report Number
    2024800-2024-00059
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    November 11, 2024
    Report Date
    December 5, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LSL
    UDI-DI
    15420045505711
    PMA / PMN Number
    K111409
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED BOTH INITIAL TEST AC2 WORKLIST (B)(4) AND RETEST AC2 WORKLIST (B)(4) AND NOTED NO HARDWARE, SOFTWARE, OR KIT-RELATED ISSUES. TS NOTED THE SAMPLES WERE EITHER LOW TARGET OR MISHANDLED. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Description of Event or Problem · 0

    ON NOVEMBER 11, 2024, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING APTIMA COMBO 2 (AC2) ASSAY MASTER LOT 902420 ON THE PANTHER INSTRUMENT. SAMPLE ID (B)(6) INITIALLY TESTED CT NEGATIVE / GC NEGATIVE. HOWEVER, THE CUSTOMER ACCIDENTALLY RETESTED THE SAME SAMPLE TUBE USING A DIFFERENT PANTHER INSTRUMENT, AND THE SAMPLE RESULTED CT POSITIVE / GC NEGATIVE. THE INITIAL CT NEGATIVE / GC NEGATIVE RESULT WAS REPORTED. HOLOGIC IS NOT AWARE IF THE RESULT WAS AMENDED OR IF THE PATIENT RECEIVED TREATMENT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489591 APTIMA COMBO 2 ASSAY DNA-REAGENTS, NEISSERIA LSL HOLOGIC, INC. 902420 15420045505711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other