BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11935761 · Received June 3, 2021

    Report

    Report Number
    2023365-2021-00073
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    September 16, 2020
    Report Date
    June 3, 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 ASYMPTOMATIC PATIENT SAMPLES THAT RESULTED POSITIVE ON ONE TARGET (ORF1AB) WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY. RUN FILES FROM X8151N WERE NOT PROVIDED FOR ANALYSIS. ACCORDING TO THE CUSTOMER, POSITIVE SAMPLES THAT WERE ABOVE 33 CTS WERE REPEATED AND RESULTED NEGATIVE. CTS ABOVE 33 ARE TYPICALLY NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. DECONTAMINATION OF THE INSTRUMENT AND WORK AREA WAS RECOMMENDED ON (B)(6) 2020. AFTER CLEANING / DECONTAMINATION WAS PERFORMED, NO FURTHER FALSE POSITIVE RESULTS OCCURRED. THE FALSE POSITIVES WERE LIKELY DUE TO ENVIRONMENTAL CONTAMINATION. THE ISSUE IS NOT CONFIRMED. A RETAIN LOT OF THE SUSPECTED DEVICE WAS TESTED ON (B)(6) 2020, FOR A SEPARATE ISSUE WITH EIGHT (8) 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# X8152N, 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# X8151N 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 ASYMPTOMATIC PATIENT SAMPLES THAT RESULTED POSITIVE ON ONE TARGET (ORF1AB) WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULTS WERE NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE CLINICAL INDICATIONS (ASYMPTOMATIC PATIENTS). NO ALLEGED HARM OCCURRED. PATIENT SAMPLES WERE NASOPHARYNGEAL SWABS IN UTM. OTHER PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832107 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 X8151N

    Patients

    Seq Age Sex Outcome Treatment
    1