BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11916742 · Received June 1, 2021

    Report

    Report Number
    2023365-2021-00064
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    August 26, 2020
    Report Date
    June 1, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 ON ONLY THE S GENE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE UPON REPEAT ON COMPETITOR ASSAYS (BIOFIRE). PICTURES OF TWO RUNS WERE PROVIDED SHOWING A SAMPLE IN WELL 1A RESULTING POSITIVE FOR THE S GENE WITH CT = 33.2 ON (B)(6) 2020 AND AGAIN ON (B)(6) 2020. IT IS NOT KNOWN IF THIS WAS THE SAME SAMPLE TESTED TWICE OR DIFFERENT SAMPLES SINCE NO ACTUAL RUNS WERE PROVIDED. THIS SAMPLE(S) WERE REPEATED ON THE COMPETITOR ASSAY (BIOFIRE) AND RESULTED NEGATIVE. IT IS KNOWN THAT THE BIOFIRE ASSAY TARGETS (ORF1AB, ORF8) ARE DIFFERENT THAN THE SIMPLEXA ASSAY (S GENE, ORF1AB). BASED ON THE INFORMATION PROVIDED, IT IS A POSSIBILITY THAT THESE SAMPLES WERE NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY WITH THE CTS = 33.2, OR THEY WERE NOT DETECTED FOR THOSE TARGETS IN THE COMPETITOR ASSAYS SINCE SAMPLES DETECTED ONLY FOR THE S GENE. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. A RETAIN LOT OF THE SUSPECTED DEVICE WAS TESTED ON (B)(6) 2020 WITH EIGHT (8) NO TEMPLATE CONTROLS (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# 7926N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151 LOT# 7926N WAS TESTED USING A TOTAL OF 35 NO-TEMPLATE CONTROLS (NTC) REPLICATES WITH ZERO (0) OCCURRENCES OF FALSE POSITIVES IN EITHER S GENE OR ORF1AB TARGETS. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. THIS IS THE 3RD COMPLAINT ON MOL4150 LOT# 7925N 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 PATIENT SAMPLES THAT RESULTED POSITIVE ON ONLY THE S GENE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE UPON REPEAT ON COMPETITOR ASSAYS (BIOFIRE). THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULTS WERE NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE COMPETITOR ASSAY AND NO ALLEGED HARM OCCURRED. PATIENT INFORMATION AND SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813837 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 7925N

    Patients

    Seq Age Sex Outcome Treatment
    1