BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HIV-1 QUANT DX ASSAY

    MDR report key: 23699832 · Received December 2, 2025

    Report

    Report Number
    2024800-2025-00075
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 2, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MZF
    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 SYSTEM LOGFILES PROVIDED BY THE CUSTOMER AND DETERMINED THAT INITIAL SAMPLE WAS LOW TARGET. REVIEW OF THE LOGS AND AMPLIFICATION CURVES DID NOT REVEAL ANY ABNORMALITIES SUGGESTIVE OF A HARDWARE OR INSTRUMENT ISSUE. HOWEVER, LOGFILE REVIEW CANNOT EXCLUDE THE POSSIBILITY OF SAMPLE MISHANDLING OR CONTAMINATION.

    Description of Event or Problem · 0

    ON NOVEMBER 12, 2025, A CUSTOMER IN FRANCE REPORTED A DISCREPANT RESULT WAS GENERATED WHEN USING THE APTIMA HIV-1 QUANT DX ASSAY (MASTER LOT 920519) WITH PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6). THE CUSTOMER NOTED THAT SAMPLE ID (B)(6) TESTED IN PANTHER WORKLIST ID (B)(4) ON (B)(6) 2025, GENERATED A VALID HIV-1 "DETECTED" RESULT WITH 120 COPIES/ML. THE OUTCOME WAS REPORTED TO THE CLINICIAN WHO QUESTIONED THE RESULT. THE CUSTOMER CONFIRMED THAT THE PATIENT IS HIV SEROPOSITIVE BUT HAD AN UNDETECTABLE VIRAL LOAD DURING THE COURSE OF HER PREGNANCY. THE PATIENT HAD BEEN UNDER TREATMENT SINCE 2017, ALTHOUGH NOT AT THE SAME HOSPITAL. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025. THE SAMPLE (ID (B)(6) WAS ANALYZED ON (B)(6) 2025, USING APTIMA HIV-1 QUANT DX ASSAY ON PANTHER WORKLIST ID (B)(4) AND GENERATED A HIV-1 "NOT DETECTED" RESULT. THE DISCREPANT RESULTS PROMPTED THE LAB TO RETEST THE ORIGINAL SAMPLE (ID (B)(6). ON (B)(6), THIS SAMPLE WAS RETESTED UNDER PANTHER WORKLIST ID (B)(4) AND GENERATED A VALID HIV-1 "NOT DETECTED" RESULT. THE SAMPLE HAD BEEN STORED AT 4°C SINCE (B)(6) 2025. THE PATIENT WAS IN THE DELIVERY ROOM WITH PREMATURE TWINS. BECAUSE THE VIRAL LOAD WAS INITIALLY REPORTED AS DETECTABLE, THE NEWBORNS RECEIVED TRIPLE ANTI-VIRAL THERAPY (LAMIVUDINE, ZIDOVUDINE AND NEVIRAPINE) DURING THE FIRST 24 HOURS. NEVIRAPINE ALONE IS THE RECOMMENDED PROPHYLAXIS IN FRANCE WHEN THE VIRAL LOAD IS UNDETECTABLE. AFTER THE NOT-DETECTED RESULT ON (B)(6) 2025, AND FOLLOWING EXPERT CONSULTATION, LAMIVUDINE AND ZIDOVUDINE WERE STOPPED. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOME RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2782692 APTIMA HIV-1 QUANT DX ASSAY TEST, HIV DETECTION MZF HOLOGIC, INC. HIV QUANT 920519

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown