BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HIV-1 QUANT DX ASSAY

    MDR report key: 22715666 · Received August 5, 2025

    Report

    Report Number
    2024800-2025-00050
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    July 17, 2025
    Report Date
    August 5, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MZF
    UDI-DI
    15420045504219
    PMA / PMN Number
    BP150318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC THOROUGHLY REVIEWED THE PANTHER LOGS AND NOTED 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. H3 OTHER TEXT: OTHER.

    Description of Event or Problem · 0

    ON JULY 18, 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THE PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6)) HAD A DISCREPANT APTIMA HIV RESULT USING THE APTIMA HIV-1 QUANT DX ASSAY (ML: 896020) UNDER WORKLIST (B)(4). THE CUSTOMER REPORTED THAT THE FIRST RUN OF THE SAMPLE PRODUCED A POSITIVE SIGNAL. THIS RESULT WAS QUESTIONED BASED ON PATIENT HISTORY. THE CUSTOMER ALSO QUESTIONED THE RESULT AS THEY RECOGNIZED AN LTR SIGNAL ARISING VERY EARLY BEFORE RAPIDLY RETURNING TO ZERO. THE CUSTOMER DECIDED TO REPEAT THE SAMPLE BEFORE REPORTING OUT THE POSITIVE RESULT. THE RETEST OF THE SAMPLE WAS NEGATIVE, AND THIS NEGATIVE RESULT WAS REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2498179 APTIMA HIV-1 QUANT DX ASSAY TEST, HIV DETECTION MZF HOLOGIC, INC. 896020 15420045504219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other