BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 15158970 · Received August 3, 2022

    Report

    Report Number
    2024800-2022-00587
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    September 13, 2021
    Report Date
    August 3, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) AND HOLOGIC PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED LOGS AND FOUND NO INSTRUMENT OR ASSAY PERFORMANCE ISSUES. PAS NOTED DISCREPANT/DISCORDANT SAMPLES COULD BE DUE TO LOW-TARGET CONCENTRATION OR SAMPLE MISHANDLING. TS SENT CUSTOMER A QA-APPROVED LETTER, AND HOLOGIC FIELD APPLICATION SPECIALIST (FAS) REACHED OUT TO CUSTOMER AND PROVIDED EXPLANATION OF RESULTS. 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

    HOLOGIC FIELD SERVICE ENGINEER (FSE) REPORTED ON BEHALF OF CUSTOMER ONE SARS-COV-2 TMA RUN, WL 002451-20210908-08, USING ASSAY LOT 289870 ON PANTHER INSTRUMENT SN (B)(4) WHICH HAD A HIGH NUMBER OF POSITIVE SAMPLES (55 POSITIVES OUT OF 207 SAMPLES). CUSTOMER QUESTIONED IF THERE WAS CONTAMINATION DUE TO THE NUMBER OF POSITIVE SAMPLES, SOME OF WHICH WERE RE-ALIQUOTED AND DID NOT REPEAT WHEN RUN ON A CEPHEID PLATFORM (SAMPLE IDS NOT PROVIDED). 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
    2082105 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 289870

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown