BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11898840 · Received May 27, 2021

    Report

    Report Number
    2023365-2021-00050
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    June 29, 2020
    Report Date
    May 27, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON 1 PATIENT SAMPLE THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY ON (B)(6) 2020, BUT REPEATED AS NEGATIVE ON ANOTHER TEST METHOD (NYS RT-PCR ASSAY) ON (B)(6) 2020. PATIENT SAMPLES WERE NASOPHARYNGEAL SWABS IN BD UVT. PATIENT WAS EXHIBITING NAUSEA, VOMITING, AND FATIGUE. RUN ANALYSIS OF THE SIMPLEXA RESULTS SHOWED SAMPLE ID (B)(4) WAS DETECTED ONLY FOR ORF1AB (CT = 39.4) ON (B)(6) 2020. A POSITIVE CONTROL WAS RUN ON THE SAME DISC AND WAS DETECTED FOR ALL TARGETS WITHOUT ISSUES (S GENE = 26.9, ORF1AB = 27.8) INDICATING THE REAGENT WAS FUNCTIONING TO SPECIFICATIONS. A SECOND SAMPLE FROM THE SAME PATIENT WAS TESTED ON THE NYS RT-PCR ASSAY AND RESULTED NEGATIVE. INFORMATION ON THE NYS RT-PCR ASSAY SHOWED THE SAMPLE WAS EXTRACTED, WHILE THE SIMPLEXA ASSAY DOES NOT EXTRACT THE SAMPLE. THE CUSTOMER THEN TESTED THE EXTRACTED SAMPLE ON BOTH SYSTEMS AND RESULTED NEGATIVE AS WELL. BASED ON THE INFORMATION PROVIDED, IT IS LIKELY THIS PATIENT SAMPLE WAS NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY DUE TO ONLY 1 TARGET (ORF1AB) BEING DETECTED AND WITH SUCH A LATE CT = 39.4. THE NYS RT-PCR ASSAY UTILIZES AN EXTRACTED SAMPLE, BUT IT IS NOT KNOWN WHAT TARGETS OF THE COVID GENE IT DETECTS. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# 7726N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. A TOTAL OF 35 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# 7725N 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 1 PATIENT SAMPLE THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY ON (B)(6) 2020, BUT REPEATED AS NEGATIVE ON ANOTHER TEST METHOD (NYS EUA ASSAY) ON (B)(6) 2020. PATIENT SAMPLES WERE NASOPHARYNGEAL SWABS IN BD UVT. PATIENT WAS EXHIBITING NAUSEA, VOMITING, AND FATIGUE. THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULT WAS NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE COMPETITOR ASSAY AND NO ALLEGED HARM OCCURRED. NO OTHER PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795235 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 7725N

    Patients

    Seq Age Sex Outcome Treatment
    1