BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 14654850 · Received June 10, 2022

    Report

    Report Number
    2024800-2022-00441
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    February 26, 2021
    Report Date
    June 10, 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) REVIEWED LOGS AND DID NOT FIND ANY INSTRUMENT OR REAGENT PREPARATION ISSUES. HOLOGIC PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED LOGS AND FOUND NO REAGENT PREPARATION ISSUES; ALL ASSAYS WERE VALID WITH EXPECTED RESULTS. PAS OBSERVED A FEW POSITIVE RLUS THROUGHOUT THE WORKLISTS BUT NOTHING CONSISTENT WITH CONTAMINATION. PAS CONCLUDED THERE WAS LIKELY SAMPLE MISHANDLING THAT CAUSED THE INCREASE IN POSITIVITY RATES. 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 MARCH 16, 2020 TO PRESENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED AN INCREASE IN POSITIVE SAMPLES FROM THEIR SARS-COV-2 TMA RUNS ON PANTHER INSTRUMENT SN (B)(4). WL 003629-20210225-31 USING ASSAY LOT 290518 WAS REVIEWED AS PART OF A GENERAL LOG REVIEW TO IDENTIFY ANY POSSIBLE CONTAMINATION. THE WL IN QUESTION HAD 22 POSITIVES OUT OF 248 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
    726400 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 290518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown