BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11935860 · Received June 3, 2021

    Report

    Report Number
    2023365-2021-00074
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    September 21, 2020
    Report Date
    June 3, 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 ELEVEN (11) PATIENT SAMPLES THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT REPEATED AS NEGATIVE BY THE CUSTOMER'S REFERENCE LAB VIA UNKNOWN METHODS. NO RUNS FROM THE SUSPECTED DEVICE WERE PROVIDED FOR ANALYSIS. NO INFORMATION ON THE REFERENCE LAB METHOD WAS PROVIDED. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE PATIENT SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. A DIASORIN MOLECULAR SENIOR SCIENTIST ADVISED THE CUSTOMER ON PROPER DECONTAMINATION OF THE INSTRUMENT AND WORK AREA AND NO FURTHER FALSE POSITIVES OCCURRED. ENVIRONMENTAL CONTAMINATION CAUSED THE ISSUE. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# 8144N, 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# 8143N 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 ELEVEN (11) PATIENT SAMPLES THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT REPEATED AS NEGATIVE BY THE CUSTOMER'S REFERENCE LAB VIA UNKNOWN METHODS. ALTHOUGH THE FALSE POSITIVE RESULTS WERE REPORTED, THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULTS DID NOT IMPACT THE PATIENTS' DIAGNOSIS OR TREATMENT SINCE IT DID NOT MATCH THE CLINICAL INDICATIONS OF THE PATIENTS. NO ALLEGED HARM OCCURRED. OTHER PATIENT INFORMATION AND SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832134 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 8143N

    Patients

    Seq Age Sex Outcome Treatment
    1