BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11914527 · Received June 1, 2021

    Report

    Report Number
    2023365-2021-00062
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    August 24, 2020
    Report Date
    June 1, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON ASYMPTOMATIC PATIENTS THAT RESULTS POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE UPON REPEAT ON A COMPETITOR ASSAY (THERMOFISHER). RUNS FROM THE SIMPLEXA ASSAY AND COMPETITOR ASSAYS WERE NOT PROVIDED FOR ANALYSIS. INVESTIGATION BY THE DIASORIN MOLECULAR SCIENTIFIC AFFAIRS SPECIALIST DETERMINED CONTAMINATION OF THE LAB CAUSED THE FALSE POSITIVE ISSUE. NO FURTHER ISSUES OCCURRED AFTER DECONTAMINATION. ISSUE NOT CONFIRMED. RETAIN TESTING IS NO LONGER POSSIBLE SINCE THE KIT LOT EXPIRED ON 11/30/2020, BUT NOT REQUIRED SINCE THE ROOT CAUSE WAS DETERMINED TO BE ENVIRONMENTAL CONTAMINATION AT THE CUSTOMER SITE. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# 7812N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151, LOT# 7812N 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# 7811N 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 PATIENTS THAT RESULTS POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE UPON REPEAT ON A COMPETITOR ASSAY (THERMOFISHER). THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULTS WERE NOT REPORTED TO A DIAGNOSING PHYSICIAN 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
    814503 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 7811N

    Patients

    Seq Age Sex Outcome Treatment
    1