BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11871609 · Received May 24, 2021

    Report

    Report Number
    2023365-2021-00035
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 20, 2020
    Report Date
    May 24, 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 NEGATIVE RESULTS ON 4 SAMPLES THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT POSITIVE ON A COMPETITOR ASSAY (CERTEST VIASSURE). THE CUSTOMER WAS VALIDATING THE SIMPLEXA ASSAY VS THE COMPETITOR ASSAY, NO PATIENT RESULTS WERE IMPACTED. THE SIMPLEXA RUNS PROVIDED BY THE CUSTOMER WERE PDFS THAT DID NOT HAVE THE AMPLIFICATION GRAPHS. NO RUN FILES WERE PROVIDED TO SEE IF THERE WAS ANY AMPLIFICATION IN THE 4 SUSPECTED FALSE NEGATIVE SAMPLES. THE FOLLOWING INFORMATION ON THE CERTEST VIASSURE WAS PROVIDED: - SAMPLE ID (B)(4) = N GENE NEGATIVE, ORF 36.3. - SAMPLE ID (B)(4) = N GENE 36.6, ORF 37. - SAMPLE ID (B)(4) = N GENE 34.9, ORF 33.4. - SAMPLE ID (B)(4) = N GENE 35.1, ORF 35.1. THERE WERE SEVERAL NOTED DIFFERENCES BETWEEN THE CERTEST ASSAY AND THE SIMPLEXA ASSAY. SAMPLES ARE EXTRACTED IN THE CERTEST ASSAY WHILE THE SIMPLEXA IS NOT. THE TARGETS ARE DIFFERENT IN THE CERTEST ASSAY (N GENE, ORF) VS SIMPLEXA (S GENE, ORF1AB). THE 4 SUSPECTED FALSE NEGATIVE SAMPLES WERE EXTRACTED AND WERE DETECTED WITH A CT RANGE = 34.9 - 37. THESE SAMPLES WERE LIKELY BEYOND THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY, BUT THE CUSTOMER'S DEVICE AND SAMPLES WERE NOT AVAILABLE FOR INVESTIGATION. 1ST COMPLAINT ON MOL4150, LOT# X8078N FOR SUSPECTED FALSE NEGATIVE RESULTS. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X8079N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151, LOT# X8079N WERE TESTED USING POSITIVE CONTROLS AND NO-TEMPLATE CONTROLS (NTC). POSITIVE CONTROLS WERE TESTED IN TRIPLICATE AND RESULTED IN ZERO (0) OCCURRENCES OF FALSE NEGATIVES IN EITHER S GENE OR ORF1AB TARGETS. ALL POSITIVE CONTROLS WERE DETECTED AT AN AVERAGE CT = 28.5 (S GENE) AND 28.9 (ORF1AB) AND THE INTERNAL CONTROL AVG CT = 32.2. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. AS STATED IN THE INSTRUCTIONS FOR USE, IFUK.US.MOL4150, "NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS MUST BE COMBINED WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, AND EPIDEMIOLOGICAL INFORMATION" AND PER THE LIMITATIONS SECTION, ITEM 5 "FALSE-NEGATIVE RESULTS MAY OCCUR IF THE VIRUSES ARE PRESENT AT A LEVEL THAT IS BELOW THE ANALYTICAL SENSITIVITY OF THE ASSAY OR IF THE VIRUS HAS GENOMIC MUTATIONS, INSERTIONS, DELETIONS, OR REARRANGEMENTS OR IF PERFORMED VERY EARLY IN THE COURSE OF ILLNESS."

    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 4 SAMPLES THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT POSITIVE ON A COMPETITOR ASSAY (CERTEST VIASSURE). THE CUSTOMER WAS VALIDATING THE SIMPLEXA ASSAY VS THE COMPETITOR ASSAY, NO PATIENT RESULTS WERE IMPACTED. THE CUSTOMER CONFIRMED THE ALLEGED FALSE NEGATIVE RESULT WAS NOT REPORTED TO A DIAGNOSING PHYSICIAN SINCE THIS WAS A VALIDATION TEST ONLY AND NO ALLEGED HARM OCCURRED. SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770230 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 X8078N

    Patients

    Seq Age Sex Outcome Treatment
    1