BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HIV-1 QUANT DX ASSAY

    MDR report key: 22366145 · Received June 30, 2025

    Report

    Report Number
    2024800-2025-00039
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    June 5, 2025
    Report Date
    June 30, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MZF
    UDI-DI
    15420045504219
    PMA / PMN Number
    BP150318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED LOGS AND KINETIC CURVES FOR BOTH INITIAL TEST WORKLIST (B)(4) AND RETEST WORKLIST (B)(4). NO HARDWARE, SOFTWARE OR CONTAMINATION ISSUES WERE FOUND. TS INFORMED THE CUSTOMER THAT RESULTS FROM DIFFERENT SAMPLE TUBES CANNOT BE DIRECTLY COMPARED. TS INDICATED THAT THE DISCREPANT RESULT WAS MOST LIKELY DUE TO THE SAMPLE LOW TARGET OR SAMPLE MISHANDLING. HOLOGIC COMPLETED A RISK ASSESSMENT. THERE IS NO PRODUCT IMPACT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT. H3 OTHER TEXT: OTHER.

    Description of Event or Problem · 0

    ON JUNE 5, 2025, A CUSTOMER REPORTED QUESTIONING RESULTS USING THE APTIMA HIV-1 QUANT DX ASSAY MASTER LOT 911588 ON PANTHER PLUS INSTRUMENT SN# (B)(6). THE CUSTOMER NOTED THAT SAMPLES FROM THE PATIENT WERE COLLECTED IN BOTH SERUM SEPARATOR TUBES (SST) AND PLASMA PREPARATION TUBES (PPT). THE DISCREPANT RESULTS ARE AS FOLLOWS: SAMPLE ID (B)(6) RETESTED AS (B)(6): ¿ ON (B)(6) 2025, THE SST WAS FIRST TESTED IN PANTHER WORKLIST: (B)(4) AND RESULTED AS ¿NOT DETECTED¿. ¿ ON (B)(6) 2025, THE SAME SST TUBE WAS RETESTED ON PANTHER AND RESULTED AS <30 DETECTED IN PANTHER WORKLIST: (B)(4). CUSTOMER ALSO TESTED A PPT SAMPLE FROM THE SAME PATIENT IN THIS WORKLIST AND THIS SAMPLE RESULTED AS 182 COPIES/ML. THE PPT TUBE WAS ALSO TESTED ON A ROCHE INSTRUMENT AND CUSTOMER STATED THIS RESULTED AS 567 COPIES/ML. THE CUSTOMER STATED THAT ALL HIV RESULTS ARE SUBJECT TO THEIR REVIEW PROCESS BEFORE DETERMINING WHICH RESULT TO REPORT. HOWEVER, THE CUSTOMER DID NOT KNOW WHICH RESULT(S) WERE REPORTED FOR SAMPLE ID (B)(6) AND IS UNABLE TO VERIFY THIS INFORMATION. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130420 APTIMA HIV-1 QUANT DX ASSAY TEST, HIV DETECTION MZF HOLOGIC, INC. 911588 15420045504219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other