BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HIV-1 QUANT DX ASSAY

    MDR report key: 20535265 · Received October 25, 2024

    Report

    Report Number
    2024800-2024-00022
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    September 29, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP150318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC SME REVIEWED THE LOGS AND OBSERVED UNUSUAL AMPLIFICATION CURVES ON ALL THREE IMPACTED PATIENT SAMPLES ID'S. FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT, CONFIRMED ISSUES WITH THE REAL TIME FLUOROMETER (RTF) HEX CHANNEL AND REPLACED THE HEX RTF MODULE. AFTER FSE SERVICE, THE CUSTOMER RETESTED THE IMPACTED PATIENT SAMPLES WITH THE APTIMA HIV-1 QUANT DX ASSAY (LOT 884343) AND ALL THREE SAMPLES GENERATED HIV-1 "NOT DETECTED" RESULTS. 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) 2024, A CUSTOMER REPORTED TO HOLOGIC THREE POTENTIAL FALSE POSITIVE RESULTS WHEN USING THE APTIMA HIV-1 QUANT DX ASSAY (LOT 884343) ON THE PANTHER INSTRUMENT SN# (B)(6). SAMPLE IDS (B)(6) INITIALLY TESTED HIV 'DETECTED¿ BUT GENERATED ¿NOT DETECTED¿ RESULTS UPON RETESTING. THE CUSTOMER DID NOT SPECIFY THE REASON THESE SAMPLES WERE RETESTED, OR WHETHER THE INITIAL TEST RESULTS HAD BEEN REPORTED. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679829 APTIMA HIV-1 QUANT DX ASSAY TEST, HIV DETECTION MZF HOLOGIC, INC. HIV QUANT 884343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown