BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11838243 · Received May 17, 2021

    Report

    Report Number
    2023365-2021-00019
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 13, 2020
    Report Date
    May 17, 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 5 PATIENT SAMPLES THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT POSITIVE ON COMPETITOR ASSAYS (SEEGENE AND ROCHE COBAS 6800). RUN FILES FROM THE SIMPLEXA ASSAY ON (B)(6) 2020 WERE ANALYZED AND THE ALLEGED FALSE NEGATIVE OCCURRED WITH 5 SAMPLES (SAMPLE IDS (B)(4)). COMPETITOR ASSAY RESULTS WERE PROVIDED FOR THE SAME 5 SAMPLES WITH THE FOLLOWING RESULTS: - SAMPLE (B)(4) RESULTED POSITIVE ON SEEGENE FOR GENE N CT 38; WEAK POSITIVE ON ROCHE FOR GENE E CT = 36,38. - SAMPLE (B)(4) RESULTED POSITIVE ON SEEGENE FOR GENE N CT 35; WEAK POSITIVE ON ROCHE FOR GENE E CT = 34,77. - SAMPLE (B)(4) RESULTED POSITIVE ON SEEGENE FOR GENE N CT 37; NO ROCHE DATA PROVIDED. - SAMPLE (B)(4) RESULTED POSITIVE ON SEEGENE FOR GENE N CT 39; WEAK POSITIVE ON ROCHE FOR GENE E CT = 32,39. - SAMPLE (B)(4) RESULTED POSITIVE ON SEEGENE FOR GENE N CT 35 AND FOR GENE RDRP CT 36; WEAK POSITIVE ON ROCHE FOR GENE E CT = 35,16. FURTHER INVESTIGATION ON THE COMPETITOR ASSAYS REVEALED DIFFERENCES IN SAMPLE PREP METHODOLOGIES. THE SEEGENE AND ROCHE EXTRACT THE SAMPLES, BUT THE SIMPLEXA SAMPLE IS DIRECT. THE TARGETS OF THE SEEGENE (N, RDRP), ROCHE (E GENE), AND SIMPLEXA ASSAY (S, (B)(4)) ARE DIFFERENT. THERE IS ALSO A DIFFERENT LIMIT OF DETECTION BETWEEN THE SIMPLEXA ASSAY (CT 33-34, 500 COPIES/UL) AND SEEGENE ASSAY (CT 40, 100 COPIES/UL). LOD/SENSITIVITY OF THE ROCHE COBAS IS NOT KNOWN. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION (B)(4) LOT#R7982NA, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. (B)(4) LOT#R7982NA 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 (B)(4) TARGETS. ALL POSITIVE CONTROLS WERE DETECTED AT AN AVERAGE CT = 28.7 (S GENE) AND 28.9 ((B)(4)) AND THE INTERNAL CONTROL AVG CT = 31.5. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. RETAIN TESTING IS NO LONGER POSSIBLE SINCE THE KIT LOT R7981N EXPIRED ON 09/30/2020, 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 ASSAYS. NO OTHER FALSE NEGATIVE RESULTS OCCURRED ON THE OTHER 11 PATIENT SAMPLES THAT WERE CORRECTLY INTERPRETED BY THE SIMPLEXA ASSAY. THE ISSUE COULD NOT BE CONFIRMED. 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 5 PATIENT SAMPLES THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT POSITIVE ON COMPETITOR ASSAYS (SEEGENE AND ROCHE COBAS). THE CUSTOMER CONFIRMED THE ALLEGED FALSE NEGATIVE RESULTS WERE NOT REPORTED TO THE DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE COMPETITOR ASSAYS. INITIAL RUNS OF THE SIMPLEXA ASSAY WERE PROVIDED. SAMPLES WERE NASOPHARYNGEAL SWABS IN UTM. THE PATIENTS WERE ASYMPTOMATIC WHEN THE SAMPLES WERE TAKEN. OTHER THAN PATIENT ID NUMBERS, OTHER PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735490 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 R7981N

    Patients

    Seq Age Sex Outcome Treatment
    1