BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 14720306 · Received June 16, 2022

    Report

    Report Number
    2024800-2022-00491
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    April 12, 2021
    Report Date
    June 16, 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; ONE SAMPLE RACK HAD A CLUSTER OF POSITIVES WITH LOWER RLUS, BUT ALL OTHER POSITIVE SAMPLES IN THE WL WERE WITHIN SPECIFICATIONS. HOLOGIC PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED LOGS AND FOUND NO REAGENT PREPARATION OR KINETICS ISSUES. PAS NOTICED A FEW SAMPLES IN THE POSITIVE CLUSTER HAD ABNORMAL SAMPLE ASPIRATION AND DISPENSE CURVES POSSIBLY INDICATING A VISCOUS/MUCOID SAMPLE THAT COULD HAVE A POTENTIAL TO CONTAMINATE, ALONG WITH THE USE OF UNAPPROVED TIPS THAT COULD CAUSE DISPENSE OR PRESSURE ERRORS. FOR THIS BATCH OF SAMPLES, CUSTOMER NOTED THAT THEIR LIQUID HANDLING ROBOT HAD ERRORS PIPETTING (WHICH IS THE CASE WHEN SAMPLES ARE MUCOIDAL) AND THEREFORE THEY HAD TO BE PIPETTED MANUALLY. CUSTOMER AGREED TO REVIEW THE HANDLING OF POSSIBLE MUCOID SAMPLES AND ARE REPLACING THE SAMPLE SHIELD MORE FREQUENTLY. 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 (B)(6) 2020 TO PRESENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED ONE SARS-COV-2 TMA RUN, WL 001064-20210408-02, USING ASSAY LOT 289484 ON PANTHER INSTRUMENT SN (B)(4) WHICH HAD POSITIVE SAMPLES THEY WERE QUESTIONING. THE WL IN QUESTION HAD 15 SUSPECTED FALSE POSITIVES OUT OF 73 SAMPLES. THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. THERE WAS NO INDICATION OF RESULTS BEING REPORTED TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252537 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 289484

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown