BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11878384 · Received May 25, 2021

    Report

    Report Number
    2023365-2021-00041
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    June 1, 2020
    Report Date
    May 25, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE NEGATIVE RESULTS ON 6 KNOWN POSITIVE PATIENT SAMPLES THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY. THE 6 PATIENT SAMPLES WERE PREVIOUSLY TESTED AS POSITIVE ON A COMPETITOR ASSAY (CEPHEID GENEXPERT) AND THE FOLLOWING INFORMATION ON THE GENEXPERT RESULTS WAS PROVIDED: - SAMPLE ID (B)(4): N2 = 38.3, E = 35.7. - SAMPLE ID (B)(4): N2 = 38.9, E = 38.9. - SAMPLE ID (B)(4): N2 = 39.0, E = 35.7. - SAMPLE ID (B)(4): N2 = 38.2, E = 38.6. - SAMPLE ID (B)(4): N2 = 24.8, E = 33.6. - SAMPLE ID (B)(4): N2 = 42.0, E = 0. NO RUN FILES FROM THE SIMPLEXA ASSAY WERE PROVIDED. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE NEGATIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. BASED ON THE INFORMATION PROVIDED ON THE COMPETITOR ASSAY, THE SUSPECTED FALSE NEGATIVE SAMPLES ARE LIKELY BEYOND THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. THE TARGETS OF THE GENEXPERT (N2 GENE, E GENE) ARE DIFFERENT THAN THE SIMPLEXA TARGETS (S GENE, ORF1AB). THE GENEXPERT ASSAY PERFORMS AND EXTRACTION OF THE SAMPLE WHILE THE SIMPLEXA ASSAY DOES NOT AND HAS A LOWER LIMIT OF DETECTION (250 COPIES/ML) THAN THE SIMPLEXA ASSAY (500 COPIES/ML). THE AVG CT VALUES OF THE N2 GENE = 38.9 AND THE E GENE = 35.9 WOULD ALSO INDICATE THESE SAMPLES ARE MOST LIKELY BEYOND THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. THE CUSTOMER IS AWARE OF THESE DIFFERENCES IN THE LIMIT OF DETECTION AND CONTINUED TO USE THE SIMPLEXA ASSAY WITHOUT FURTHER ISSUES. THIS IS THE 3RD 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. RETAIN TESTING IS NO LONGER POSSIBLE SINCE THE KIT LOT X8078N EXPIRED ON 10/31/2020, BUT BASED ON THE INFORMATION PROVIDED, THE ALLEGED FALSE NEGATIVE SAMPLES WERE MOST LIKELY BEYOND THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY IN COMPARISON TO THE COMPETITOR ASSAY. 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 6 KNOWN POSITIVE PATIENT SAMPLES THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY. THE 6 PATIENT SAMPLES WERE PREVIOUSLY TESTED AS POSITIVE ON A COMPETITOR ASSAY (CEPHEID GENEXPERT). THE CUSTOMER CONFIRMED THE ALLEGED FALSE NEGATIVE RESULTS WERE NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE PREVIOUSLY POSITIVE RESULTS OBTAINED WITH THE COMPETITOR ASSAY AND NO ALLEGED HARM OCCURRED. THE SAMPLES WERE NASOPHARYNGEAL SAMPLES. OTHER THAN THE PATIENT SAMPLE IDS, OTHER PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778311 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