BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11903158 · Received May 28, 2021

    Report

    Report Number
    2023365-2021-00053
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    August 6, 2020
    Report Date
    May 28, 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 A PATIENT SAMPLE THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150, LOT# X8645N, BUT RESULTED POSITIVE FOR BOTH S GENE AND ORF1AB WHEN REPEATED ON A DIFFERENT LOT OF SIMPLEXA ASSAY. THE SAME SAMPLE WAS TESTED ON A COMPETITOR ASSAY (CEPHEID GENEXPERT) AND RESULTED POSITIVE. THE PATIENT SAMPLE WAS ALREADY DETERMINED POSITIVE VIA PCR ANALYSIS PRIOR TO RUNNING ON THE SIMPLEXA ASSAY AND MATCHED THE CLINICAL OBSERVATIONS (PATIENT ALREADY HAD BILATERAL PNEUMONIA). RUN ANALYSIS OF SIMPLEXA RESULTS SHOWED ONE SAMPLE ID (B)(4) WAS NEGATIVE ON THE SIMPLEXA ASSAY ON (B)(6) 2020 AT 1:30AM AND THEN REPEATED THE SAME DAY ON A DIFFERENT LOT OF SIMPLEXA ASSAY AT 1215PM AND RESULTED POSITIVE FOR S GENE (CT = 35.8) AND ORF1AB (31.1). ACCORDING TO THE CUSTOMER, THE SAMPLE WAS DETECTED BY THE GENEXPERT ASSAY WITH CT = 43. IT IS KNOWN THAT THE GENEXPERT HAS KEY DIFFERENCES (EXTRACTS SAMPLE, TARGETS E GENE / N2 GENE, AND A LIMIT OF DETECTION OF 250 COPIES/ML) COMPARED TO THE SIMPLEXA ASSAY (NO SAMPLE EXTRACTION, TARGETS S GENE / ORF1AB, AND LOD OF 500 COPIES/ML). THE CUSTOMER'S DEVICE AND SUSPECTED FALSE NEGATIVE SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. DUE TO THE LATER CTS OBSERVED IN BOTH THE SIMPLEXA ASSAY (S GENE CT = 35.8) AND THE GENEXPERT (CT = 43), IT IS LIKELY THIS SAMPLE WAS NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. THIS IS THE 2ND COMPLAINT ON MOL4150, LOT# X8645N FOR SUSPECTED FALSE NEGATIVE RESULTS. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X8646N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151, LOT# X8646N 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 = 27.6 (S GENE) AND 27.7 (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 A PATIENT SAMPLE THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150, LOT# X8645N, BUT RESULTED POSITIVE FOR BOTH S GENE AND ORF1AB WHEN REPEATED ON A DIFFERENT LOT OF SIMPLEXA ASSAY. THE SAME SAMPLE WAS TESTED ON A COMPETITOR ASSAY (CEPHEID GENEXPERT) AND RESULTED POSITIVE. THE PATIENT SAMPLE WAS ALREADY DETERMINED POSITIVE VIA PCR ANALYSIS PRIOR TO RUNNING ON THE SIMPLEXA ASSAY AND MATCHED THE CLINICAL OBSERVATIONS (PATIENT ALREADY HAD BILATERAL PNEUMONIA). THE CUSTOMER CONFIRMED THE ALLEGED FALSE NEGATIVE RESULTS WERE NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH PREVIOUSLY POSITIVE PCR RESULT AND REPEAT POSITIVE ON THE COMPETITOR ASSAY. NO ALLEGED HARM OCCURRED. OTHER THAN THE PATIENT SAMPLE IDS, OTHER PATIENT INFORMATION AND SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801756 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 X8645N

    Patients

    Seq Age Sex Outcome Treatment
    1