BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11873549 · Received May 24, 2021

    Report

    Report Number
    2023365-2021-00038
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    May 9, 2020
    Report Date
    May 24, 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 2 PATIENT SAMPLES THAT TESTED POSITIVE FOR 1 TARGET (ORF1AB) WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT RESULTED NEGATIVE WHEN TESTING ON THE COMPETITOR ASSAY (SEEGENE) AND REPEAT ON THE SIMPLEXA ASSAY. THE SAMPLES WERE TESTED ON BOTH PLATFORMS ON THE SAME DAY AND WERE KEPT AT 4C BETWEEN RUNS. RUN ANALYSIS OF THE SIMPLEXA RESULTS SHOW 2 SAMPLES WERE DETECTED - SAMPLE 1D DETECTED ONLY THE ORF1AB WITH CT = 35.4 AND SAMPLE 1G DETECTED ONLY ORF1AB WITH CT = 33.1. NO DATA WAS PROVIDED ON THE COMPETITOR ASSAY, BUT IT IS KNOWN FROM PREVIOUS INVESTIGATIONS THAT THE SEEGENE ASSAY TARGETS (E GENE, N GENE, RDRP) ARE DIFFERENT THAN THE SIMPLEXA ASSAY (S GENE, ORF1AB). IT IS LIKELY THESE 2 SAMPLES WERE NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY BASED ON THE LATER CT VALUES OF ONLY THE ORF1AB DETECTED AND WERE NOT DETECTED BY THE COMPETITOR ASSAY DUE TO THE DIFFERENT TARGETS NOT DETECTED. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. RETAIN TESTING WAS COMPLETED ON 6/4/2020 WITH 35 REPLICATES OF NO TEMPLATE CONTROL (NTC) AND ZERO (0) FALSE POSITIVES OCCURRED IN EITHER THE S GENE OR ORF1AB TARGETS. NO MALFUNCTIONS WERE DETECTED DURING RETAIN TESTING. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X8192N, 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# X8191N 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 2 PATIENT SAMPLES THAT TESTED POSITIVE FOR 1 TARGET (ORF1AB) WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT RESULTED NEGATIVE WHEN TESTING ON THE COMPETITOR ASSAY (SEEGENE) AND REPEAT ON THE SIMPLEXA ASSAY. THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULT WAS NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE REPEAT TEST AND COMPETITOR ASSAY AND NO ALLEGED HARM OCCURRED. OTHER PATIENT INFORMATION AND PATIENT SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770205 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 X8191N

    Patients

    Seq Age Sex Outcome Treatment
    1