BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11903794 · Received May 28, 2021

    Report

    Report Number
    2023365-2021-00054
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    August 5, 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 4 PATIENT SAMPLES WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE ON COMPETITOR ASSAYS (PANTHER, SEEGENE, CEPHEID GENEXPERT). RUN ANALYSIS OF THE SIMPLEXA RESULTS SHOWED POSITIVE RESULTS ON 4 SAMPLES: - SAMPLE ID (B)(4): DETECTED S GENE (CT = 31.3), ORF1AB (CT = 31.1). - SAMPLE ID (B)(4): DETECTED S GENE (CT = 30.9), ORF1AB (CT = 31.0). - SAMPLE ID (B)(4) (TESTED TWICE): DETECTED S GENE (CT = 28.6, 30.8), ORF1AB (CT = 30.0, 35.4). - SAMPLE ID (B)(4): DETECTED ONLY ORF1AB (CT = 38.6). ACCORDING TO THE CUSTOMER, ALL 4 OF THESE SAMPLES TESTED NEGATIVE ON THE COMPETITOR ASSAYS (PANTHER, SEEGENE, CEPHEID GENEXPERT). NO PATIENT INFORMATION WAS PROVIDED ON THE SUSPECTED FALSE POSITIVE RESULTS. IT IS UNKNOWN IF THE PATIENTS WERE SYMPTOMATIC OR ASYMPTOMATIC. DATA FROM THE COMPETITOR ASSAYS WAS NOT PROVIDED, BUT IT IS KNOWN THE ASSAY TARGETS ARE DIFFERENT FROM THE SIMPLEXA ASSAY (S GENE AND ORF1AB) - PANTHER DETECTS ORF1AB REGION 1 AND 2, SEEGENE DETECTS N GENE AND RDRP GENE, AND GENEXPERT DETECTS E GENE AND N2 GENE. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. RETAINS WERE TESTED FOR A DIFFERENT ISSUE ON 8/19/2020. 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. THE ISSUE COULD NOT BE CONFIRMED. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X8646N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151, LOT# X8646N 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. THIS IS THE 1ST COMPLAINT ON MOL4150, LOT# X8645N 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 4 PATIENT SAMPLES WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE ON COMPETITOR ASSAYS (PANTHER, SEEGENE, CEPHEID GENEXPERT). THE PATIENT SAMPLES ARE NASOPHARYNGEAL IN UTM. THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULT WAS NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE COMPETITOR ASSAYS 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
    801764 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 X8645N

    Patients

    Seq Age Sex Outcome Treatment
    1