BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 14125345 · Received April 15, 2022

    Report

    Report Number
    1650733-2022-00010
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 15, 2022
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. HOWEVER, THE MDR IS BEING SUBMITTED TO US FDA PURSUANT TO THE OBLIGATIONS OF THE EMERGENCY USE AUTHORIZATION, AND PER COMMUNICATION RECEIVED FROM FDA ON OCTOBER 7, 2020.

    Description of Event or Problem · 0

    ON (B)(6) 2022: THE CUSTOMER REQUESTED A CASE BE OPENED FOR ARIES SARS-COV-2 CASSETTES LOT AB5143A FAILING PATIENT VALIDATIONS. THE CUSTOMER REPORTED 19 FALSE NEGATIVES AFTER TESTING PATIENT SAMPLES ON THEIR ARIES INSTRUMENT THAT WERE PREVIOUSLY RUN ON THEIR CEPHEID SYSTEM. OF THESE, 8 SAMPLES REPORTED FALSE NEGATIVES. SAMPLES WERE FIRST RAN ON THEIR CEPHEID SYSTEM AND LATER RAN ON THEIR ARIES INSTRUMENT (WITHIN A FEW MINUTES OF GETTING RESULTS FROM CEPHEID). BOTH ARIES MODULES WERE UTILIZED. SAMPLE ID: (B)(6), SAMPLE/MEDIA: NPS IN UTM, SAMPLE TYPE: PATIENT SAMPLES. ON (B)(6) 2022: LUMINEX TS REQUESTED THE CEPHID RESULTS IN ORDER TO COMPARE CT VALUES BETWEEN THE PLATFORMS. THE CUSTOMER DID NOT PROVIDE THE CEPHID DATA. THE ROOT CAUSE OF THE FALSE NEGATIVE RESULT IS UNKNOWN AT THIS TIME; HOWEVER, IT IS SUSPECTED THE SENSITIVITY OF THE ARIES SARS-COV-2 ASSAY PLAYS A ROLE IN THESE RESULTS WHEN COMPARED TO THE OTHER PLATFORMS. LUMINEX TECH SUPPORT SENT THE CUSTOMER AN EXTRA SARS-COV-2 KIT FOR TROUBLESHOOTING. ON (B)(6) 2022: THE CUSTOMER REPORTED POSITIVE AND NEGATIVE CONTROLS ON BOTH MODULES RESULTED IN THE EXPECTED RESULTS. HOWEVER, THE CUSTOMER RERAN A TEST FROM POSITIVE PATIENT SAMPLE ID: (B)(6), WHICH RESULTED IN A FALSE NEGATIVE ONCE AGAIN. THE CUSTOMER PICKED OUT 2 SAMPLES FROM THE 8 TOTAL FALSE NEGATIVES ON THEIR ARIES INSTRUMENT AND RERAN THEN ON THE FILMARRAY BIOFIRE, WHICH RESULTED POSITIVE FOR THE 2 SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889431 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION 50-10047 AB5143A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown