BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HIV-1 QUANT DX ASSAY

    MDR report key: 22523575 · Received July 16, 2025

    Report

    Report Number
    2024800-2025-00043
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 16, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MZF
    UDI-DI
    15420045504219
    PMA / PMN Number
    BP150318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC REVIEWED THE PANTHER LOGS AND KINETIC CURVES FOR WORKLIST 000940-20250606-03 AND NOTED THAT THE INITIAL SAMPLE CURVE EXHIBITED AN ATYPICAL LOW BASELINE FLUORESCENCE. THIS LOW FLUORESCENCE RETURNED TO NORMAL EARLY IN THE ASSAY PROCESS. AS A RESULT, THE SOFTWARE PRODUCED A HIGH TITER RESULT FOR THIS SAMPLE. HOLOGIC PERFORMED A RISK ASSESSMENT. OVER-QUANTIFICATION OF HIV VIRAL LOAD MAY LEAD TO A CHANGE IN ANTIRETROVIRAL THERAPY (ART) OR UNNECESSARY INITIATION OF ART TREATMENT. HOWEVER, UNDER STANDARD HIV VIRAL LOAD MONITORING GUIDELINES, A CHANGE IN PATIENT VIRAL LOAD IS TO BE CONFIRMED PRIOR TO CHANGE IN PATIENT TREATMENT. IN ADDITION, UPON INITIATION OF ART TREATMENT, CLINICIANS ARE EXPECTED TO INTERPRET ASSAY RESULTS IN CONJUNCTION WITH PATIENT HISTORY AND OTHER AVAILABLE DATA. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CUSTOMER REPORTED QUESTIONING RESULTS USING THE APTIMA HIV-1 QUANT DX ASSAY MASTER LOT: 896020 ON PANTHER PLUS INSTRUMENT SN#: (B)(6). THE CUSTOMER NOTED SAMPLE ID: (B)(6) WAS TESTED IN PANTHER WORKLIST: 000940-20250606-03 AND RESULTED WITH >10,000,000 COPIES/ML BUT THE SAMPLE CURVE WAS POOR. ON (B)(6) 2025, THE CUSTOMER STATED THAT THEY HAVE NO REMAINING SAMPLE LEFT FOR RETESTING AS THE REMAINING SAMPLE WAS SENT TO THE REFERENCE LABORATORY FOR TESTING. THE REFERENCE LABORATORY WAS UNABLE TO AMPLIFY ANY PRODUCT. ON (B)(6) 2025, CUSTOMER STATED THAT THE >10,000,000 COPIES/ML RESULT WAS REPORTED OUT TO THE CONSULTANT. NO INFORMATION REGARDING PATIENT TREATMENT WAS PROVIDED. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162143 APTIMA HIV-1 QUANT DX ASSAY TEST, HIV DETECTION MZF HOLOGIC, INC. 896020 15420045504219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other