BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 15108389 · Received July 26, 2022

    Report

    Report Number
    2024800-2022-00545
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    May 12, 2021
    Report Date
    July 26, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED LOGS AND DID NOT OBSERVE ANY SIGN OF REAGENT PREPARATION OR INSTRUMENT ISSUES. TS NOTED THE SAMPLES WITH LOWER RLUS HAD LOWER ANALYTE SIGNAL, BUT NO OVERALL KINETICS ISSUES WERE OBSERVED. TS PROVIDED 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 (B)(6) 2020 TO PRESENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED AN INCREASE IN LOW POSITIVE SAMPLES ON THEIR SARS-COV-2 TMA RUNS USING ASSAY LOT 290566 ON PANTHER INSTRUMENT SN (B)(4) AND QUESTIONED THEIR VALIDITY. HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED WL 001374-20210511-01, WHICH HAD 2 POSITIVES OUT OF 158 SAMPLES, 1 OF WHICH WAS A LOW POSITIVE (800 RLUS). 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
    707726 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 290566

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown