BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 14503242 · Received May 26, 2022

    Report

    Report Number
    1650733-2022-00033
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 9, 2022
    Report Date
    May 25, 2022
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN REVIEW OF ALL CASE DETAILS AGAINST THE CRITERIA SET FORTH IN DOCUMENT 00043 (MEDICAL DEVICE REPORTING STANDARD OPERATING PROCEDURE) AND ITS APPLICABLE APPENDICES, THIS COMPLAINT DOES NOT MEET THE REQUIREMENTS FOR AN MDR IN THE COUNTRIES WHERE THE DEVICE IS SOLD OR DISTRIBUTED.

    Description of Event or Problem · 0

    MAS REPORTED CUSTOMER HAS SEEN A FALSE NEGATIVE RESULT WHILE RUNNING A PATIENT SAMPLE ON THE SARS-COV-2 ASSAY. THE CUSTOMER RAN SAMPLE 192599 ON USING A RAPID METHOD AND GOT POSITIVE RESULT ON THE RAPID METHOD AND A NEGATIVE RESULT ON THE ARIES. TS REQUESTED RUN FILES. ARIES RUN RESULT: SARS-COV-2 NEGATIVE. ROCHE COBAS LIAT RESULT: SARS-COV-2 POSITIVE. CUSTOMER REPORTED USING 0.9% BUFFERED SALINE SWAB, WHICH WAS VALIDATED BY THE CUSTOMER. THE CUSTOMER PERFORMED THE VALIDATION STUDY AGAINST M4 MEDIA PRIOR TO PUTTING THE INSTRUMENT INTO USE IN 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889503 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB5299

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown