BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 15160856 · Received August 3, 2022

    Report

    Report Number
    2024800-2022-00591
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    September 17, 2021
    Report Date
    August 3, 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 PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED LOGS AND DETERMINED THIS WAS A CONTAMINATION ISSUE BASED ON THE NUMBER OF POSITIVE SAMPLES IN A ROW FOR THIS WL. PAS ADVISED THAT CUSTOMER SHOULD REPLACE THE SAMPLE SHIELD, DECONTAMINATE THE LAB, PREPARE A NEW REAGENT KIT, AND RUN PANEL A'S TO GET A BASELINE RESULT. HOLOGIC TECHNICAL SUPPORT (TS) RELAYED PAS REVIEW 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 AN INCREASE IN POSITIVITY RATE ON THEIR SARS-COV-2 TMA RUNS USING ASSAY LOT 296997 ON PANTHER INSTRUMENT SN (B)(4). THE SAMPLES WERE FROM THE SAME COLLECTION SITE. THE WL IN QUESTION, 003945-20210914-11, HAD 70 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 BEINGS REPORTED TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703881 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 296997

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown