BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11971093 · Received June 9, 2021

    Report

    Report Number
    2023365-2021-00094
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    February 22, 2021
    Report Date
    June 9, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE NEGATIVE RESULTS ON ONE (1) PATIENT SAMPLE THAT INITIALLY RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT POSITIVE ON A COMPETITOR ASSAY (CEPHEID GENEXPERT) AND ALSO ON TWO DIFFERENT LOTS OF SIMPLEXA ASSAY. RUN ANALYSIS OF THE SIMPLEXA RESULTS FROM 2/25/2021 SHOWED ONE SAMPLE ID (B)(4) WAS NEGATIVE FOR BOTH TARGETS. THE CUSTOMER STATED THE SAME SAMPLE WAS TESTED THE SAME DAY ON THE COMPETITOR CEPHEID GENEXPERT AND WAS DETECTED WITH CT = 19.5. A NEW SAMPLE WAS OBTAINED AND RUN ON TWO DIFFERENT LOTS OF SIMPLEXA ASSAY ON 3/6/2021 (MOL4151, LOT# X9691N) AND 3/7/2021 (MOL4151, LOT# X9704N). THE RESULTS WERE AS FOLLOWS: - 3/6/2021: SAMPLE POSITIVE: S GENE (CT = 24.6), ORF1AB (CT = 27.3), IC (CT = 31.3). - 3/7/2021: SAMPLE POSITIVE : S GENE (CT = 20.3), ORF1AB (CT = 21.9), IC (CT = 32.1). IN BOTH CASES, A POSITIVE CONTROL WAS RUN WITH ALL TARGETS DETECTED WITHOUT ISSUES AND A NEGATIVE CONTROL WITHOUT ISSUES. THE CUSTOMER STATED THE INTIAL SAMPLE WAS IN VTM MANUFACTURED BY OZYME, AN UNKNOWN VTM SUPPLIER. THERE IS A POSSIBILITY THAT THE TRANSPORT MEDIA INTERFERED WITH THE INITIAL RESULT AS IT WAS AN UNKNOWN SUPPLIER OF VTM. WITHOUT THE SUSPECTED FALSE NEGATIVE SAMPLE, THIS COULD NOT BE CONFIRMED. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE NEGATIVE SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. IT IS KNOWN THE GENEXPERT TARGETS ARE DIFFERENT (E GENE, N2 GENE) THAN THE SIMPLEXA ASSAY (S GENE, ORF1AB), AND THE GENEXPERT EXTRACTS THE SAMPLE WHILE THE SIMPLEXA ASSAY DOES NOT. BASED ON THIS INFORMATION, IT IS LIKELY THE INITIAL SAMPLE CONTAINED INHIBITORS THAT PREVENTED DETECTION OF THE S GENE AND ORF1AB TARGETS OF THE SIMPLEXA ASSAY, BUT NOT THE E GENE AND N2 GENE OF THE GENEXPERT ASSAY. THE GENEXPERT'S USE OF EXTRACTION OF THE SAMPLE REMOVES ANY INHIBITORS THAT COULD HAVE BEEN PRESENT IN THE INITIAL SAMPLE. THIS IS THE 1ST COMPLAINT ON MOL4150 LOT# X9125N FOR SUSPECTED FALSE NEGATIVE RESULTS. RETAINS OF THE SUSPECTED DEVICE WERE TESTED ON 4/8/2021 WITH TWO DISCS OF EIGHT (8) REPLICATES OF MOL4160 POSITIVE CONTROL (16 TOTAL REPLICATES) AND BOTH S GENE (AVG CT = 25.8, 26.6) AND ORF1AG (AVG CT = 27.0, 27.0) WERE DETECTED ON ALL REPLICATES. NO FALSE NEGATIVES OCCURRED. NO MALFUNCTIONS OCCURRED. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X9326N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151, LOT# X9326N 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 = 26.9 (S GENE) AND 27.5 (ORF1AB) AND THE INTERNAL CONTROL AVG CT = 31.0. 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."

    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 ONE (1) PATIENT SAMPLE THAT INITIALLY RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT POSITIVE ON A COMPETITOR ASSAY (CEPHEID GENEXPERT) AND ALSO ON TWO DIFFERENT LOTS OF SIMPLEXA ASSAY. THE CUSTOMER CONFIRMED THE ALLEGED FALSE NEGATIVE RESULT WAS NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE COMPETITOR ASSAY AND REPEAT TESTS. NO ALLEGED HARM OCCURRED. THE PATIENT SAMPLE WAS NASOPHARYNGEAL SWAB IN VTM. OTHER THAN THE PATIENT SAMPLE IDS, OTHER PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868214 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 X9125N

    Patients

    Seq Age Sex Outcome Treatment
    1