BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11904853 · Received May 28, 2021

    Report

    Report Number
    2023365-2021-00057
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    August 17, 2020
    Report Date
    May 28, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON SEVERAL SAMPLES INCLUDING JUST TRANSPORT MEDIUM WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY. SEVERAL RUNS WERE PROVIDED WITH A TOTAL OF 29 POSITIVES WITH MANY HAVING STRONG POSITIVES (10-20 CTS). BASED ON THE INFORMATION PROVIDED WITH VERY EARLY CTS AND FALSE POSITIVES OCCURRING ON JUST THE TRANSPORT MEDIA ITSELF, IT WAS RECOMMENDED TO THE CUSTOMER TO DECONTAMINATE THE INSTRUMENT AND WORK AREA AND PERFORM ENVIRONMENTAL TESTING. THE DIASORIN SUBSIDIARY IN (B)(4) WORKED WITH THE CUSTOMER AND RESOLVED THEIR CONTAMINATION PROBLEM. NO FURTHER FALSE POSITIVES OCCURRED. CONTAMINATION HAD CAUSED THE ISSUE. ISSUE NOT CONFIRMED. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X8150N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151, LOT# X8150N WERE 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# X8149N 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 SEVERAL SAMPLES INCLUDING JUST TRANSPORT MEDIUM WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULTS WERE NOT REPORTED TO A DIAGNOSING PHYSICIAN AND NO ALLEGED HARM OCCURRED. OTHER THAN THE PATIENT SAMPLE ID, OTHER PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801850 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 X8149N

    Patients

    Seq Age Sex Outcome Treatment
    1