BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11902956 · Received May 28, 2021

    Report

    Report Number
    2023365-2021-00052
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    July 17, 2020
    Report Date
    May 28, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON 1 PATIENT SAMPLE THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY ON (B)(6) 2020, BUT THEN REPEATED THE NEXT DAY ON THE SAME SIMPLEXA ASSAY THAT RESULTED NEGATIVE. THE SAME SAMPLE WAS REPEATED AGAIN ON (B)(6) 2020 AS NEGATIVE ON THE SIMPLEXA ASSAY AND ANOTHER TEST METHOD (NYS RT-PCR ASSAY). RUN ANALYSIS OF THE SIMPLEXA RESULTS SHOWED 1 SAMPLE ID (B)(4) WAS POSITIVE WITH ONE TARGET ORF1AB (CT = 34.5). THE PATIENT SAMPLE IS NASOPHARYNGEAL SWAB IN BD VTM. ADDITIONAL INFORMATION ON THE NYS ASSAY WAS PROVIDED AND SHOWED DIFFERENT TARGETS (N1 GENE, N2 GENE) COMPARED TO THE SIMPLEXA ASSAY (S GENE, ORF1AB). IT IS KNOWN FROM A PREVIOUS COMPLAINT THAT THE NYS ASSAY USES EXTRACTED SAMPLES WHILE THE SIMPLEXA ASSAY DOES NOT. BASED ON THE INFORMATION PROVIDED, IT IS LIKELY THIS PATIENT SAMPLE WAS NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY DUE TO THE SINGLE TARGET DETECTION WITH LATE CTS AND THE DIFFERENT TARGETS OF THE NYS ASSAY. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# 7726N, 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 2ND COMPLAINT ON MOL4150, LOT# 7725N 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 1 PATIENT SAMPLE THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY ON (B)(6) 2020, BUT THEN REPEATED THE NEXT DAY ON THE SAME SIMPLEXA ASSAY THAT RESULTED NEGATIVE. THE SAME SAMPLE WAS REPEATED AGAIN ON (B)(6) 2020 AS NEGATIVE ON THE SIMPLEXA ASSAY AND ANOTHER TEST METHOD (NYS RT-PCR ASSAY). THE PATIENT SAMPLE IS NASOPHARYNGEAL SWAB IN BD VTM. THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULT WAS NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY ON REPEAT AND WITH THE COMPETITOR ASSAY 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
    801697 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 7725N

    Patients

    Seq Age Sex Outcome Treatment
    1