BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11971262 · Received June 9, 2021

    Report

    Report Number
    2023365-2021-00095
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    February 23, 2021
    Report Date
    June 9, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 FOR ONE TARGET (S GENE) WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE ON A COMPETITOR ASSAY (TIB MOLBIOL). RUN ANALYSIS OF THE SIMPLEXA RESULTS SHOWED ONE SAMPLE ID (B)($) WAS POSITIVE FOR ONLY THE S GENE (CT = 34.0) WHEN TESTED ON 2/23/2021. ACCORDING TO THE CUSTOMER, THE SAME SAMPLE WAS TESTED ON THE COMPETITOR ASSAY, ROCHE AND TIB MOLBIOL, AND RESULTED NEGATIVE. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLE WERE NOT PROVIDED FOR INVESTIGATION. IT IS KNOWN THE ROCHE TARGETS (ORF1AB, E GENE) AND TIBMOLBIOL TARGETS (E GENE, RDRP) ARE DIFFERENT THAN THE SIMPLEXA ASSAY (S GENE, ORF1AB). WITH THE DETECTION OF ONLY THE S GENE, IT IS UNLIKELY THE COMPETITOR ASSAYS WOULD DETECT THIS LOW POSITIVE SAMPLE. RETAIN TESTING IS NO LONGER POSSIBLE SINCE THE KIT LOT EXPIRED ON 04/30/2021 BUT A POTENTIAL CAUSE IS EITHER THE SAMPLE WAS NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY AND JUST NOT DETECTED BY THE COMPETITOR ASSAYS, OR THE SAMPLE WAS CONTAMINATED. WITHOUT THE SAMPLE, THIS COULD NOT BE CONFIRMED. THIS IS A SAMPLE SPECIFIC ISSUE ONLY. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X9563N, 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# X9089N 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 FOR ONE TARGET (S GENE) WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE ON A COMPETITOR ASSAY (TIB MOLBIOL). THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULT WAS NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE COMPETITOR ASSAY AND NO ALLEGED HARM OCCURRED. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF THE TEST AND WAS BEING TESTED PER TRAVEL REQUIREMENTS. THE SAMPLE WAS NASOPHARYNGEAL SWAB IN SALINE. OTHER THAN THE PATIENT SAMPLE IDS, OTHER PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868215 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 X9089N

    Patients

    Seq Age Sex Outcome Treatment
    1