BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11888536 · Received May 26, 2021

    Report

    Report Number
    2023365-2021-00045
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    June 16, 2020
    Report Date
    May 26, 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 POSITIVE RESULTS ON A PATIENT SAMPLE THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY ON (B)(6) 2020, BUT REPEATED AS NEGATIVE WHEN TESTED ON THE SAME SIMPLEXA ASSAY ON (B)(6) 2020. THE SAME SAMPLE RESULTED NEGATIVE ON COMPETITOR ASSAYS (THERMOFISHER, SEEGENE). RUN ANALYSIS ON THE SIMPLEXA RESULT SHOWED ONE SAMPLE ID (B)(6) WAS DETECTED ONLY FOR ORF1AB (CT = 34.3) ON (B)(6) 2020 AND THEN RESULTED NEGATIVE ON (B)(6) 2020. IT IS NOT KNOWN WHEN THE SAMPLE WAS TESTED ON THE COMPETITOR ASSAYS, BUT THERE ARE KEY DIFFERENCES BETWEEN THE SIMPLEXA ASSAY AND THE COMPETITORS: COMPETITOR TARGETS (THERMOFISHER = S GENE, N GENE, ORF1AB, SEEGENE = N GENE, RDRP) ARE DIFFERENT THAN THE SIMPLEXA ASSAY (S GENE, ORF1AB). THERMOFISHER AND SEEGENE ASSAYS EXTRACT THE SAMPLE WHILE THE SIMPLEXA ASSAY DOES NOT. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLE WAS NOT PROVIDED FOR INVESTIGATION, BUT IT IS LIKELY THE SAMPLE IS NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. RETAIN TESTING IS NO LONGER POSSIBLE ON THE KIT LOT X7749N SINCE IT EXPIRED ON 10/31/2020, BUT IT IS LIKELY THIS WAS A SAMPLE SPECIFIC ISSUE BASED ON THE LATE CT ON ONLY THE ORF1AB THAT WERE AT THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# X7750N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. A TOTAL OF 35 NO-TEMPLATE CONTROL (NTC) REPLICATES WERE RUN AND RESULTED IN ZERO (0) OCCURRENCES OF FALSE POSITIVES IN EITHER S GENE OR ORF1AB TARGETS. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. THIS IS THE 1ST COMPLAINT ON MOL4150 LOT# X7750N FOR SUSPECTED FALSE POSITIVE RESULTS.

    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 POSITIVE RESULTS ON A PATIENT SAMPLE THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY ON (B)(6) 2020, BUT REPEATED AS NEGATIVE WHEN TESTED ON THE SAME SIMPLEXA ASSAY ON (B)(6) 2020. THE SAME SAMPLE RESULTED NEGATIVE ON COMPETITOR ASSAYS (THERMOFISHER, SEEGENE). THE PATIENT WAS ASYMPTOMATIC AT THE TIME THE NASOPHARYNGEAL SAMPLE IN UTM WAS DRAWN. ALTHOUGH THE FALSE POSITIVE RESULT WAS REPORTED TO THE DIAGNOSING PHYSICIAN, THE CUSTOMER CONFIRMED THAT TREATMENT WAS NOT IMPACTED DUE TO THE DISCREPANCY WITH THE CLINICAL INDICATIONS (ASYMPTOMATIC PATIENT). NO ALLEGED HARM OCCURRED. NO OTHER PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787474 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 X7749N

    Patients

    Seq Age Sex Outcome Treatment
    1