BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 14462688 · Received May 20, 2022

    Report

    Report Number
    2024800-2022-00294
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    October 22, 2020
    Report Date
    May 20, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED LOGS AND FOUND NO INSTRUMENT OR REAGENT PREPARATION ISSUES. HOLOGIC PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED LOGS AND FOUND NO INSTRUMENT OR ASSAY PERFORMANCE ISSUES. CUSTOMER RETESTED A NEW ALIQUOT OF THE SAMPLE IN QUESTION, AND IT RESULTED NEGATIVE; PAS NOTED THIS WOULD BE CONSIDERED A NEW SAMPLE AND SHOULD NOT BE COMPARED TO THE ORIGINAL. PAS CONCLUDED THE SAMPLE WAS LIKELY LOW-TITER AND INCLUDED THAT IT WAS RETESTED ON A LESS SENSITIVE PLATFORM. TS RELAYED PAS'S FINDINGS TO CUSTOMER. NO FURTHER ISSUES REPORTED. HOLOGIC AND FDA MET ON (B)(6) 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 000969-20201015-22, USING ASSAY LOT 276791 ON PANTHER INSTRUMENT SN (B)(4) WHICH HAD A DISCREPANT SAMPLE. THE SAMPLE WAS INITIALLY POSITIVE, THEN WAS STORED FROZEN AND RETESTED NEGATIVE ON A BD MAX PLATFORM AND BIOGX REAGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526435 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 276791

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown