BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11856941 · Received May 20, 2021

    Report

    Report Number
    2023365-2021-00026
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    May 18, 2020
    Report Date
    May 20, 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 2 PATIENT SAMPLES THAT RESULTED POSITIVE FOR ONLY ONE TARGET (ORF1AB) WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE UPON REPEAT ON BOTH THE SIMPLEXA ASSAY AND A COMPETITOR METHOD (SEEGENE). RUN ANALYSIS OF THE INITIAL SIMPLEXA ASSAY RUNS FROM 5/18/2020 AND 5/19/2020 SHOWED 2 SAMPLES WERE DETECTED FOR ONLY THE ORF1AB: SAMPLE 1B CT = 35.2 AND SAMPLE 1G CT = 33.3. THE HIGHER CT VALUES INDICATE IT IS LIKELY THESE SAMPLES WERE NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY AND MAY NOT BE DETECTED UPON REPEAT. REPEAT RUNS FROM THE SIMPLEXA ASSAY AND THE COMPETITOR METHOD WERE NOT PROVIDED. IT IS NOTED THAT THE COMPETITOR SEEGENE ASSAY TARGETS (E GENE, N GENE, RDRP) ARE DIFFERENT THAN THE SIMPLEXA ASSAY (S GENE, ORF1AB). THE CUSTOMER'S DEVICE AND PATIENT SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X8341N, 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. POSITIVE CONTROLS WERE TESTED IN TRIPLICATE AND DETECTED FOR BOTH GENES WITH AN AVG CT = 28.1 (S GENE) AND 29.4 (ORF1AB). NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. RETAIN TESTING IS NO LONGER POSSIBLE SINCE THE KIT LOT X7773N EXPIRED ON 11/30/2020, BUT BASED ON THE INFORMATION PROVIDED, THIS WAS A SAMPLE SPECIFIC ISSUE SINCE IT IS LIKELY NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. NO OTHER FALSE POSITIVES OCCURRED ON OTHER PATIENT SAMPLES TESTED ON THE SAME RUNS. THE ISSUE COULD NOT BE CONFIRMED. THIS IS THE 1ST COMPLAINT ON MOL4150, LOT# X7773N 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 2 PATIENT SAMPLES THAT RESULTED POSITIVE FOR ONLY ONE TARGET (ORF1AB) WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE UPON REPEAT ON BOTH THE SIMPLEXA ASSAY AND A COMPETITOR METHOD (SEEGENE). THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULTS WERE NOT REPORTED TO THE DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY AFTER REPEAT TESTING ON THE SIMPLEXA ASSAY AND COMPETITOR METHOD. NO ALLEGED HARM OCCURRED. OTHER THAN PATIENT SAMPLE IDS, OTHER PATIENT INFORMATION AND SAMPLE TYPE INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757202 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 X7773N

    Patients

    Seq Age Sex Outcome Treatment
    1