BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 14789166 · Received June 23, 2022

    Report

    Report Number
    2024800-2022-00526
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    October 15, 2021
    Report Date
    June 23, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED LOGS AND NOTED THE FOLLOWING RUN HAD AN EXPECTED POSITIVITY RATE, SO THE ISSUE APPEARED TO BE ISOLATED TO THE WL IN QUESTION. HOLOGIC PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED LOGS AND FOUND NO INSTRUMENT OR REAGENT PREPARATION ISSUES; THERE WERE MULTIPLE POSITIVE SAMPLES IN A ROW WHICH COULD INDICATE CONTAMINATION WHEN HANDLING. PAS ADVISED CUSTOMER ON HOW TO AVOID SAMPLE MISHANDLING AND SUGGESTED TO RERUN THE POSITIVE SAMPLES IF THEY COULD RECOLLECT. NO FURTHER ISSUES REPORTED. HOLOGIC AND FDA MET ON OCTOBER 29, 2021, REGARDING HOW TO REPORT ALL "FALSE/DISCREPANT/QUESTIONING RESULTS" COMPLAINTS FOR THE APTIMA AND PANTHER FUSION SARS-COV-2 ASSAYS (PANTHER FUSION SARS-COV-2 (EUA(B)(4)), APTIMA SARS-COV-2 (EUA(B)(4)), AND APTIMA SARS-COV-2/FLU (EUA(B)(4)). FDA CLARIFIED THAT AS PART OF THE CONDITIONS FOR THE EMERGENCY USE AUTHORIZATION OF SARS-COV-2 ASSAYS, MANUFACTURERS ARE REQUIRED TO TRACK ADVERSE EVENTS INCLUDING ANY OCCURRENCE OF "FALSE/DISCREPANT/QUESTIONING RESULTS", CONFIRMED OR UNCONFIRMED, AND REPORT TO FDA IN ACCORDANCE WITH 21 CFR PART 803. HOLOGIC, RETROSPECTIVELY IS REPORTING COMPLAINTS INITIATED FROM (B)(6) 2020 TO PRESENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ONE SARS-COV-2 TMA RUN, WL 010337-20211013-12, USING ASSAY LOT 304923 ON PANTHER PLUS INSTRUMENT SN (B)(4) WHICH HAD A HIGHER RATE OF POSITIVE SAMPLES THAN EXPECTED. THE WL IN QUESTION HAD 13 POSITIVES OUT OF 38 SAMPLES (34% POSITIVITY RATE), SO CUSTOMER WAS CONCERNED ABOUT POSSIBLE CONTAMINATION. THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. THERE WAS NO INDICATION OF RESULTS BEING REPORTED TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240957 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 304923

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown