BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11917232 · Received June 1, 2021

    Report

    Report Number
    2023365-2021-00065
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    September 3, 2020
    Report Date
    June 1, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON 5 PATIENT SAMPLES THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE UPON REPEAT ON A COMPETITOR ASSAY (BD MAX). RUN ANALYSIS ON THE SIMPLEXA ASSAY SHOWED AT LEAST 7 PATIENT SAMPLES THAT WERE DETECTED, BUT THE CUSTOMER DID NOT INDICATE WHICH FIVE WERE CONSIDERED FALSE POSITIVE. THE POSITIVE SAMPLES WERE AS FOLLOWS: SAMPLE ID (B)(6): S GENE (CT = 35.4), ORF1AB (CT = 33.3). SAMPLE ID (B)(6): S GENE (CT = 34). SAMPLE ID (B)(6): S GENE (CT = 32.9). SAMPLE ID (B)(6): S GENE (CT = 33), ORF1AB (CT = 34). SAMPLE ID (B)(6): S GENE (CT = 32.3), ORF1AB (CT = 33.8). SAMPLE ID (B)(6): ORF1AB (CT = 34). RETESTED SAME DAY: S GENE (CT = 32.9), ORF1AB (CT = 32.7). SAMPLE ID (B)(6): S GENE (CT = 34.1), ORF1AB (CT = 34). OF THE 7 SAMPLES, 6 SAMPLES HAD DETECTIONS WITH A CT RANGE = 33 - 35.4 WHICH IS NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. IN ALL 7 SAMPLES THE S GENE WAS DETECTED BY THE SIMPLEXA ASSAY. IT IS KNOWN THAT THE BD MAX ASSAY DETECTS THE N1 AND N2 GENES. BASED ON THIS INFORMATION, IT IS LIKELY THESE SAMPLES WERE NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY AND NOT DETECTED BY THE COMPETITOR ASSAY'S DIFFERENT GENE TARGETS, BUT THE SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. THE CUSTOMER'S DEVICE WAS ALSO NOT PROVIDED FOR INVESTIGATION. A RETAIN LOT OF THE SUSPECTED DEVICE WAS TESTED ON (B)(6) 2020 WITH EIGHT (16) 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# 8437N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151 LOT# 8437N 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 1ST COMPLAINT ON MOL4150 LOT# 8404N 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 5 PATIENT SAMPLES THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE UPON REPEAT ON A COMPETITOR ASSAY (BD MAX). FOUR (4) OUT OF FIVE (5) OF THE PATIENTS WERE ASYMPTOMATIC. THE FIFTH PATIENT WAS ALREADY HOSPITALIZED IN THE ICU FOR RESPIRATORY FAILURE DUE TO MULTIFOCAL PNEUMONIA PRIOR TO TESTING ON THE SIMPLEXA ASSAY. ALTHOUGH THE FALSE POSITIVE RESULTS WERE REPORTED, THE CUSTOMER CONFIRMED NO ALLEGED HARM OCCURRED. NO DEATH OR SERIOUS INJURY OCCURRED AS A RESULT OF THE FALSE POSITIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814532 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 8404N

    Patients

    Seq Age Sex Outcome Treatment
    1