BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 14317283 · Received May 7, 2022

    Report

    Report Number
    2024800-2022-00213
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    July 31, 2020
    Report Date
    May 6, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED LOGS AND CONFIRMED THE POSITIVE TEST RESULTS WERE LOW-POSITIVES. HOLOGIC PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED LOGS AND FOUND NO INSTRUMENT, KINETICS, OR ASSAY PERFORMANCE ISSUES. THE KINETICS OF THE NEGATIVE RESULT DID NOT MEET THE THRESHOLD FOR POSITIVITY, SO PAS CONCLUDED THIS WAS LIKELY A LOW-TARGET SAMPLE. TS RELAYED THIS INFORMATION 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 (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 SAR-COV-2 TMA RUN, 000942-20200730-29, USING ASSAY LOT 276791 ON PANTHER INSTRUMENT SN (B)(4) WHICH HAD A DISCREPANT SAMPLE. CUSTOMER ACCIDENTALLY TESTED THE SAMPLE IN TRIPLICATE; THE FIRST RESULT WAS NEGATIVE WHILE THE SECOND AND THIRD RESULTS WERE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078183 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 276791

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown