BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11881990 · Received May 25, 2021

    Report

    Report Number
    2023365-2021-00043
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    May 29, 2020
    Report Date
    May 25, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON A PATIENT SAMPLE THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE ON OTHER COMPETITOR ASSAYS (CEPHEID GENEXPERT, VIASURE, SEEGENE). RUN ANALYSIS OF THE SIMPLEXA RESULT SHOWED ONE SAMPLE ID (B)(4) DETECTED ONLY THE ORF1AB (CT = 36.1). THIS IS A RELATIVELY LATE DETECTION ON THE SIMPLEXA ASSAY. IT IS NOT KNOWN WHEN THE SAMPLE WAS RUN ON THE COMPETITOR ASSAYS, BUT THERE ARE KEY DIFFERENCES BETWEEN THE SIMPLEXA ASSAY AND THE COMPETITORS: - COMPETITOR TARGETS (GENEXPERT = E, N2 GENE, SEEGENE = N, RDRP GENE) ARE DIFFERENT THAN SIMPLEXA ASSAY (S GENE, ORF1AB) - GENEXPERT, SEEGENE EXTRACTS THE SAMPLE WHILE THE SIMPLEXA ASSAY DOES NOT. IT IS NOT CLEAR WHICH VIASURE PRODUCT WAS USED BY THE CUSTOMER. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. RETAIN TESTING IS NO LONGER POSSIBLE ON THE KIT LOT X7751N SINCE IT EXPIRED ON 10/31/2020, BUT IT IS LIKELY THIS WAS A SAMPLE SPECIFIC ISSUE BASED ON THE LATE CTS ON ONLY THE ORF1AB THAT WERE AT THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. THE COMPETITOR ASSAY HAVE DIFFERENT TARGETS, SO IT IS NOT CLEAR WHICH WAS THE CORRECT RESULT. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X7752N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. A TOTAL OF (B)(4) NO-TEMPLATE CONTROL (NTC) REPLICATES WERE RUN AND RESULTED IN ZERO (0) OCCURRENCES OF FALSE POSITIVES IN EITHER S GENE OR ORF1AB TARGETS. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. THIS IS THE 1ST COMPLAINT ON MOL4150, LOT# X7751N FOR SUSPECTED FALSE POSITIVE RESULTS.

    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 POSITIVE RESULTS ON A PATIENT SAMPLE THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE ON OTHER COMPETITOR ASSAYS (CEPHEID GENEXPERT, VIASURE, SEEGENE). THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULT WAS NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE COMPETITOR ASSAYS AND NO ALLEGED HARM OCCURRED. THE PATIENT SAMPLE WAS A NASOPHARYNGEAL SWAB IN UTM. OTHER THAN THE PATIENT SAMPLE ID, OTHER PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778689 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 X7751N

    Patients

    Seq Age Sex Outcome Treatment
    1