BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 14574720 · Received June 2, 2022

    Report

    Report Number
    2024800-2022-00371
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    December 15, 2020
    Report Date
    June 2, 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 STATED THAT MOST POSITIVE SAMPLES IN THIS WL WERE ADJACENT TO OR SANDWICHED BETWEEN TWO POSITIVES. GIVEN THAT THEIR SAMPLE RESULTS FROM ONE DAY WERE IN QUESTION BASED ON WORKFLOW ISSUES, IT WAS LIKELY THE SAMPLES IN QUESTION WERE CONTAMINATED DURING SAMPLE HANDLING OR PIPETTING. CUSTOMER UNDERSTOOD AND AGREED TO THOROUGHLY CLEAN THEIR WORK AREAS. 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 003424-20201212-11, USING ASSAY LOT 275732 ON PANTHER INSTRUMENT SN (B)(4) WHICH HAD 8 SUSPECTED FALSE POSITIVE SAMPLES. THE SAMPLES WERE INITIALLY POSITIVE BUT WERE NEGATIVE WHEN RETESTED ON ANOTHER PANTHER. 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
    215629 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 275732

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown