BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11865410 · Received May 21, 2021

    Report

    Report Number
    2023365-2021-00031
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    May 8, 2020
    Report Date
    May 21, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE NEGATIVE RESULTS ON A PATIENT SAMPLE THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT PREVIOUSLY TESTED POSITIVE ON A COMPETITOR ASSAY (LUMINEX MAGPIX). NO RUN FILES COULD BE PROVIDED BY THE CUSTOMER AFTER SEVERAL ATTEMPTS FROM (B)(6) 2020 - (B)(6) 2020. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE NEGATIVE SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. LOT INFORMATION ON THE SIMPLEXA ASSAY WAS NOT PROVIDED. RESULTS FROM THE COMPETITOR ASSAY WAS NOT PROVIDED. THE CUSTOMER STATED THE COMPETITOR ASSAY USES EXTRACTED SAMPLES WHILE THE SIMPLEXA ASSAY DOES NOT, BUT WITHOUT RUN FILES TO COMPARE RESULTS, THE ISSUE COULD NOT BE CONFIRMED. NO FURTHER INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT EMERGENCY USE AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTICS TESTS, PER THE CONDITIONS OF AUTHORIZATION FOR THIS PRODUCT, SUSPECTED FALSE NEGATIVES AND FALSE POSITIVES WILL BE REPORTED UNDER 21 CFR 803, AS WELL AS SIGNIFICANT CHANGES IN EXPECTED PERFORMANCE CHARACTERISTICS. THERE HAS BEEN NO REPORT OF PATIENT INJURY/DEATH DUE TO CONTRIBUTION OF ALLEGED FALSE TESTING RESULTS IN THIS EVENT OR OTHERS WITH THIS IVD; HOWEVER, THIS IS BEING REPORTED CONSERVATIVELY IN THE CASE THAT IF THIS ALLEGED MALFUNCTION WERE TO RECUR THERE IS A NON-REMOTE POTENTIAL FOR A PATIENT TO INCUR A SERIOUS INJURY/DEATH. DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE NEGATIVE RESULTS ON A PATIENT SAMPLE THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT PREVIOUSLY TESTED POSITIVE ON A COMPETITOR ASSAY (LUMINEX MAGPIX). THE CUSTOMER CONFIRMED THE ALLEGED FALSE NEGATIVE RESULT WAS NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE COMPETITOR ASSAY AND NO ALLEGED HARM OCCURRED. THE PATIENT SAMPLE WAS NASOPHARYNGEAL SWAB IN 1ML UTM. OTHER PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761481 SIMPLEXA COVID-19 DIRECT ASSAY REAL TIME RT-PCR ASSAY FOR THE IVD QUALITATIVE DETECTION OF SARS-COV-2 VIRAL RNA QJR DIASORIN MOLECULAR LLC NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1