BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11852637 · Received May 19, 2021

    Report

    Report Number
    2023365-2021-00025
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 11, 2020
    Report Date
    May 19, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE NEGATIVE RESULTS ON 8 PATIENT SAMPLES THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT POSITIVE UPON REPEAT TESTING WITH THE COMPETITOR ASSAY, SEEGENE ALLPLEX2019-NCOVASSAY. THE 8 POSITIVE RESULTS FROM THE COMPETITOR ASSAY WERE DETECTED WITH A CT RANGE = 34-39 WITH 4 OF THE 8 POSITIVES ONLY DETECTING 1 OF THE SEEGENE TARGET GENES (N GENE OR RDRP). RUN ANALYSIS OF SIMPLEXA ASSAY RESULTS SHOWED NO DETECTION ON THE 8 SAMPLES THAT WERE POSITIVE ON THE SEEGENE ASSAY (SAMPLE IDS: (B)(4)). ACCORDING TO THE SUMMARY OF SEEGENE RESULTS PROVIDED BY THE CUSTOMER: - SAMPLE IDS (B)(4) WERE DETECTED FOR ONLY GENE N WITH CTS GREATER THAN 39. - SAMPLE IDS (B)(4) WERE DETECTED FOR BOTH GENES N AND RDRP WITH A CT RANGE = 34-37 - SAMPLE IDS (B)(4) WERE DETECTED FOR ONLY GENE N WITH CTS GREATER THAN 36. IT WAS CLEAR FROM THE COMPETITOR ASSAY RESULTS SUMMARY THAT THE TARGETS FOR THE SEEGENE ASSAY *(N GENE, RDRP) ARE DIFFERENT THAN THE SIMPLEXA ASSAY (S GENE, ORF1AB). IN ADDITION, THE COMPETITOR ASSAY UTILIZES EXTRACTION OF THE SAMPLE WHEREAS THE SIMPLEXA ASSAY DOES NOT. NO DEVICE AND NO PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X8075N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151, LOT# X8075N 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 = 28.6 (S GENE) AND 29.1 (ORF1AB) AND THE INTERNAL CONTROL AVG CT = 31.8. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. RETAIN TESTING IS NO LONGER POSSIBLE SINCE THE KIT LOT X8074N EXPIRED ON 09/30/2020, BUT BASED ON THE INFORMATION PROVIDED, THIS WAS A SAMPLE SPECIFIC ISSUE AS ONLY THE SEEGENE TARGETS WERE DETECTED AND NOT THE SIMPLEXA ASSAY TARGETS. AS WITH EXTRACTED SAMPLES, IT IS MOST LIKELY SOME INTERFERING SUBSTANCES IN THE DIRECT SAMPLE THAT PREVENTS DETECTION OF THE SIMPLEXA ASSAY TARGETS. WITH THE LATE CTS EVEN IN THE EXTRACTED SEEGENE ASSAY, IT IS ALSO LIKELY THESE SAMPLES WERE BEYOND THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. NO OTHER FALSE NEGATIVES OCCURRED ON OTHER PATIENT SAMPLES TESTED ON THE SAME RUNS. THE ISSUE COULD NOT BE CONFIRMED. THIS IS THE 2ND COMPLAINT ON MOL4150 LOT# X8074N FOR SUSPECTED FALSE NEGATIVE RESULTS. 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 8 PATIENT SAMPLES THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT POSITIVE UPON REPEAT TESTING WITH THE COMPETITOR ASSAY, SEEGENE ALLPLEX2019-NCOVASSAY. THE CUSTOMER CONFIRMED THE ALLEGED FALSE NEGATIVE RESULTS WERE NOT REPORTED TO THE DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE COMPETITOR METHOD AND NO ALLEGED HARM OCCURRED. PATIENT SAMPLES WERE COLLECTED IN COPAN UTM OR MBVIR MICROBIOTECH SWAB). OTHER THAN PATIENT SAMPLE ID NUMBERS, OTHER PATIENT INFORMATION AND PATIENT SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749209 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 X8074N

    Patients

    Seq Age Sex Outcome Treatment
    1