BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11860207 · Received May 20, 2021

    Report

    Report Number
    2023365-2021-00028
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 22, 2020
    Report Date
    May 20, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE NEGATIVE RESULTS ON PATIENT SAMPLES THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT POSITIVE ON AN UNKNOWN COMPETITOR ASSAY. THE CUSTOMER CONFIRMED THEY ARE USING AN OFF-LABEL, "HOME BREWED" TRANSPORT MEDIA THAT IS MANUFACTURED BY THEIR PHARMACY IN AN UNCONTROLLED ENVIRONMENT. THE SUSPECTED FALSE NEGATIVE RESULTS ARE ONLY OCCURING WITH THIS OFF-LABEL TRANSPORT MEDIA. NO RUN FILES WERE PROVIDED FOR ANALYSIS. NO LOT INFORMATION WAS PROVIDED. NO DEVICE OR PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. SOME OF THE OFF-LABEL TRANSPORT MEDIA WAS PROVIDED BY THE CUSTOMER TO DIASORIN MOLECULAR R&D TO TEST IT'S COMPATIBILITY WITH THE SIMPLEXA COVID-19 DIRECT ASSAY AND IT WAS DETERMINED THE CUSTOMER'S OFF-LABEL TRANSPORT MEDIA IS MOST LIKELY THE CAUSE OF THE SUSPECTED FALSE NEGATIVES. NO FURTHER INVESTIGATION WAS REQUIRED DUE TO THE OFF-LABEL USE. ISSUE IS NOT CONFIRMED.

    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 PATIENT SAMPLES THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT POSITIVE ON AN UNKNOWN COMPETITOR ASSAY. THE CUSTOMER IS USING AN OFF-LABEL, "HOME BREWED" TRANSPORT MEDIA. THE SUSPECTED FALSE NEGATIVE RESULTS ARE ONLY OCCURING WITH THIS OFF-LABEL TRANSPORT MEDIA. THE CUSTOMER CONFIRMED THE ALLEGED FALSE NEGATIVE RESULTS WERE NOT REPORTED TO THE DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE UNKNOWN TESTING METHOD AND NO ALLEGED HARM OCCURRED. NO SPECIFIC LOT INFORMATION WAS PROVIDED. PATIENT INFORMATION AND PATIENT SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757323 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