BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11864087 · Received May 21, 2021

    Report

    Report Number
    2023365-2021-00029
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 24, 2020
    Report Date
    May 21, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE NEGATIVE RESULTS ON 6 KNOWN POSITIVE SAMPLES THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY. A TOTAL OF 12 SAMPLES WERE PREVIOUSLY TESTED ON THEIR LAB DEVELOPED TEST AND RESULTED POSITIVE. NO RUN FILES WERE PROVIDED BY THE CUSTOMER FOR ANALYSIS. NO INFORMATION ON THE CUSTOMER'S LAB DEVELOPED TEST (LDT) WAS PROVIDED. THE CUSTOMER STATED THAT 6 OUT OF THE 12 KNOWN POSITIVE SAMPLES HAD CT VALUES RANGING FROM THE LOW TO UPPER 30S, AND ONLY 1 OF THOSE 6 SAMPLES WAS A "STRONG POSITIVE". A DIASORIN FIELD APPLICATION SCIENTIST WAS IN COMMUNICATIONS WITH THE CUSTOMER AND DETERMINED THE SAMPLES WERE MOST LIKELY NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. FURTHER INVESTIGATION REVEALED THE CUSTOMER'S LAB DEVELOP TEST USES EXTRACTED SAMPLES WHILE THE SIMPLEXA ASSAY DOES NOT. FOLLOW UP QUESTIONS WERE EMAILED TO THE CUSTOMER REQUESTING THEIR LDT'S LIMIT OF DETECTION AND RUN FILES FOR ANALYSIS, BUT NEITHER WERE PROVIDED. ON (B)(6) 2020, THE CUSTOMER STATED THEY WERE ABLE TO CONTINUE WITH THEIR VALIDATION OF THE SIMPLEXA ASSAY. NO FURTHER ISSUES WERE DETECTED. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# 7748N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151, LOT# 7748N WERE TESTED USING POSITIVE CONTROLS AND NO-TEMPLATE CONTROLS (NTC). POSITIVE CONTROLS WERE TESTED IN TRIPLICATE AND RESULTED IN ZERO (0) OCCURRENCES OF FALSE NEGATIVES IN EITHER S GENE OR ORF1AB TARGETS. ALL POSITIVE CONTROLS WERE DETECTED AT AN AVERAGE CT = 28.3 (S GENE) AND 28.4 (ORF1AB) AND THE INTERNAL CONTROL AVG CT = 31.8. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. RETAIN TESTING IS NO LONGER POSSIBLE SINCE THE KIT LOT 7747N EXPIRED ON 10/31/2020, BUT BASED ON THE INFORMATION PROVIDED, THE ALLEGED FALSE NEGATIVE SAMPLES WERE MOST LIKELY BEYOND THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY IN COMPARISON TO THE CUSTOMER'S LDT. NO OTHER FALSE NEGATIVE RESULTS OCCURRED ON THE OTHER SAMPLES THAT WERE CORRECTLY INTERPRETED BY THE SIMPLEXA ASSAY. THE ISSUE COULD NOT BE CONFIRMED. THIS IS THE 1ST COMPLAINT ON MOL4150, LOT# 7747N FOR SUSPECTED FALSE NEGATIVE RESULTS. AS STATED IN THE INSTRUCTIONS FOR USE, IFUK.US.MOL4150, "NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS MUST BE COMBINED WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, AND EPIDEMIOLOGICAL INFORMATION" AND PER THE LIMITATIONS SECTION, ITEM 5 "FALSE-NEGATIVE RESULTS MAY OCCUR IF THE VIRUSES ARE PRESENT AT A LEVEL THAT IS BELOW THE ANALYTICAL SENSITIVITY OF THE ASSAY OR IF THE VIRUS HAS GENOMIC MUTATIONS, INSERTIONS, DELETIONS, OR REARRANGEMENTS OR IF PERFORMED VERY EARLY IN THE COURSE OF ILLNESS."

    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 NEGATIVE RESULTS ON 6 KNOWN POSITIVE SAMPLES THAT RESULTED NEGATIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY. A TOTAL OF 12 SAMPLES WERE PREVIOUSLY TESTED ON THEIR LAB DEVELOPED TEST AND RESULTED POSITIVE. THE CUSTOMER CONFIRMED THE ALLEGED FALSE NEGATIVE RESULTS WERE NOT REPORTED TO A DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THEIR LAB DEVELOPED TEST AND NO ALLEGED HARM OCCURRED. PATIENT INFORMATION AND PATIENT SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761413 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 7747N

    Patients

    Seq Age Sex Outcome Treatment
    1