BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 14712504 · Received June 16, 2022

    Report

    Report Number
    2024800-2022-00482
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    April 7, 2021
    Report Date
    June 16, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED THE LOGS AND OBSERVED A SLIGHT INCREASE IN THE POSITIVE CONTROL RLU FOR ML 286240 COMPARED TO ML 286020. TS NOTED THE WL IN QUESTION WAS VALID WITH NO INDICATIONS OF HARDWARE ISSUES. TS ADVISED CUSTOMER THE SHIFT IN RLUS FROM LOT-TO-LOT WAS NORMAL, AND THERE WAS NOTHING TO SUGGEST A KIT ISSUE. CUSTOMER UNDERSTOOD AND DID NOT REPORT ANY FURTHER ISSUE. 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 (B)(4), APTIMA SARS-COV-2 (B)(4), AND APTIMA SARS-COV-2/FLU (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 MARCH 16, 2020 TO PRESENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ONE SARS-COV-2 TMA KIT, ASSAY LOT: 286240, WHICH HAD ELEVATED NEGATIVE AND POSITIVE CONTROL RLUS COMPARED TO PREVIOUS LOTS. HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED WL 001333-20210406-04 WHICH WAS RUN ON PANTHER INSTRUMENT SN: (B)(4) USING THE AFFECTED KIT. THERE WAS NO INDICATION OF RESULTS BEING QUESTIONED OR REPORTED TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130313 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 286240

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown