BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11959983 · Received June 8, 2021

    Report

    Report Number
    2023365-2021-00088
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    December 9, 2020
    Report Date
    June 8, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULT ON A SAMPLE THAT RESULTED POSITIVE WHEN VALIDATING THE USE OF THE SIMPLEXA COVID-19 DIRECT ASSAY ON (B)(6) 2020, BUT WAS PREVIOUSLY NEGATIVE ON A COMPETITOR ASSAY (BIOFIRE) ON (B)(6) 2020. SCIENTIFIC AFFAIRS REVIEWED THE CUSTOMER'S DATA, AND REPORTED THAT BECAUSE BIOFIRE USES THE S GENE, THIS COULD RESULT IN A POSSIBLE MISSED DETECTION OF THE CIRCULATING VARIANT BY THE DIASORIN PLATFORM AND WHY OUR ASSAY ONLY DETECTED THE ORF1AB. THE SAMPLE ID (B)(4) WAS POSITIVE FOR ONLY ORF1AB (CT = 35.8). DUE TO THE LATE CT, REPEATING MIGHT NOT GENERATE REPRODUCIBLE RESULTS BECAUSE IT IS WITHIN THE LOD OF OUR ASSAY. NO KIT-RELATED PRODUCT DEFICIENCIES OR MALFUNCTIONS, AND NO IMPACT TO PATIENT TESTING. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLE WERE NOT PROVIDED FOR INVESTIGATION. OTHER SAMPLES ON THE SAME RUN MATCHED THE RESULTS OF THE BIOFIRE WITHOUT ISSUES. RETAIN TESTING IS NO LONGER POSSIBLE SINCE THE KIT LOT EXPIRED ON 05/31/2021 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 ASSAY, 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# 9686N, 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# 9098N 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 RESULT ON A SAMPLE THAT RESULTED POSITIVE WHEN VALIDATING THE USE OF THE SIMPLEXA COVID-19 DIRECT ASSAY ON (B)(6) 2020, BUT WAS PREVIOUSLY NEGATIVE ON A COMPETITOR ASSAY (BIOFIRE) ON (B)(6) 2020. THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULT WAS NOT REPORTED TO A DIAGNOSING PHYSICIAN SINCE IT WAS A VALIDATION ONLY. 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
    859928 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 9098N

    Patients

    Seq Age Sex Outcome Treatment
    1