BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 14565579 · Received June 1, 2022

    Report

    Report Number
    2024800-2022-00360
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    December 7, 2020
    Report Date
    June 1, 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 LOGS AND CONFIRMED THE RLU VALUES FOR THE ENTIRE WL WERE LOW. HOLOGIC PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED LOGS, AGREED WITH TS'S FINDINGS, AND FOUND NO INSTRUMENT ISSUES. PAS NOTED THE AMPLIFICATION AND ENZYME REAGENT CAPS MAY HAVE BEEN SWAPPED DURING REAGENT PREPARATION. TS RELAYED PAS'S REVIEW TO CUSTOMER. 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 (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 RUN, WL 002452-20201206-26, USING ASSAY LOT 278948 ON PANTHER FUSION INSTRUMENT SN (B)(4) WHICH HAD 53 LOW POSITIVES OUT OF 248 SAMPLES. CUSTOMER RERAN ALL LOW POSITIVES (<1000 RLUS) IN THIS WL, AND ALL BUT ONE SAMPLE WAS CONFIRMED AS POSITIVE. THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. THERE WAS NO INDICATION OF RESULTS BEINGS REPORTED TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462031 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 278948

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown