BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11958994 · Received June 8, 2021

    Report

    Report Number
    2023365-2021-00087
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    November 27, 2020
    Report Date
    June 8, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 ONLY ONE GENE (ORF1AB) WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE ON A COMPETITOR ASSAY (ROCHE COBAS) AND WHEN REPEATED ON THE SIMPLEXA ASSAY. RUN ANALYSIS OF THE SIMPLEXA RESULT SHOWED ONE SAMPLE ID (B)(4) WAS POSITIVE FOR ORF1AB (CT = 35.7). THE SAME SAMPLE WAS TESTED ON THE COMPETITOR ASSAY (ROCHE COBAS) AND RESULTED NEGATIVE. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. IT IS KNOWN THE ROCHE ASSAY USES EXTRACTED SAMPLES WHILE THE SIMPLEXA ASSAY DOES NOT. BASED ON THE INFORMATION PROVIDED, THE POTENTIAL CAUSE IS EITHER THE SAMPLE WAS NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY (DUE TO THE LATE CT IN ORF1AB), OR THE INITIAL SAMPLE WAS CONTAMINATED. WITHOUT THE CUSTOMER'S DEVICE OR PATIENT SAMPLE, THIS POTENTIAL CAUSE COULD NOT BE CONFIRMED. A RETAIN LOT OF THE SUSPECTED DEVICE WAS PREVIOUSLY TESTED ON 10/2/2020 FOR A SEPARATE ISSUE WITH 16 NO TEMPLATE CONTROL (NTC) REPLICATES AND ZERO (0) FALSE POSITIVES OCCURRED IN EITHER S GENE OR ORF1AB TARGETS. THE ALLEGED FALSE POSITIVES COULD NOT BE REPLICATED WITH THE NTC TESTING THAT MIMICKED NEGATIVE SAMPLE TESTING. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X8164N, 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 WAS THE 2ND COMPLAINT ON MOL4150, LOT# X8163N 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 ONLY ONE GENE (ORF1AB) WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE ON A COMPETITOR ASSAY (ROCHE COBAS) AND WHEN REPEATED ON THE SIMPLEXA ASSAY. THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULT WAS NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE COMPETITOR ASSAY AND THE AUSTRALIA REQUIREMENT THAT ALL TARGETS NEED TO BE DETECTED. NO ALLEGED HARM OCCURRED. OTHER THAN THE PATIENT SAMPLE IDS, OTHER PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859907 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 X8163N

    Patients

    Seq Age Sex Outcome Treatment
    1