BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVD-19 DIRECT ASSAY

    MDR report key: 11798128 · Received May 10, 2021

    Report

    Report Number
    2023365-2021-00004
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 6, 2021
    Report Date
    March 12, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON 2 ASYMPTOMATIC PATIENT SAMPLES TESTED ON THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150 LOT# 10127N. PATIENT INFORMATION WAS REQUESTED ON 4/6/2021 BUT NO RESPONSE HAS BEEN GIVEN BY THE CUSTOMER AS OF 5/7/2021. THE CUSTOMER HAS NOT RETURNED ANY ISSUE KITS FOR INVESTIGATION NOR HAVE THEY PROVIDED ANY PATIENT SAMPLES FOR TESTING. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# X11575N, 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. FOLLOW UP REPORT 7/1/21: RETAIN TESTING COMPLETED ON 5/15/21 WITH 14 NO TEMPLATE CONTROL (NTC) REPLICATES AND ZERO (0) FALSE POSITIVES OCCURRED IN EITHER S GENE OR ORF1AB TARGETS. THE ALLEGED FALSE POSITIVES COULD NOT BE "REPLICATED" WITH THE NTC TESTING THAT MIMICKED NEGATIVE SAMPLE TESTING. IT IS KNOWN THE COMPETITOR ASSAY (CEPHEID GENEXPERT) HAS DIFFERENT TARGETS (E GENE, N2 GENE) THAN THE SIMPLEXA ASSAY (S GENE, ORF1AB). BASED ON THE INFORMATION PROVIDED, THE POTENTIAL CAUSE IS EITHER THE SAMPLES WERE NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY DUE TO THE LATE DETECTION (CTS = 36.4, 38.3), OR THE INITIAL SAMPLES WERE CONTAMINATED. WITHOUT THE CUSTOMER'S DEVICE OR PATIENT SAMPLES, THIS POTENTIAL CAUSE COULD NOT BE CONFIRMED. THIS IS THE 1ST COMPLAINT ON MOL4150 LOT# 10127N FOR SUSPECTED FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    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 ON 4/6/2021 ALLEGING FALSE POSITIVE RESULTS ON 2 ASYMPTOMATIC PATIENT SAMPLES TESTED ON THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150 LOT# 10127N. THE SAMPLE FROM THE 1ST ASYMPTOMATIC PATIENT RESULTED NEGATIVE ON THE INITIAL SIMPLEXA TEST ON (B)(6) 2021, AND THEN RESULTED POSITIVE ON REPEAT TESTING 1 WEEK LATER ON (B)(6) 2021 (CT = 36.4), AND THEN REPEATED AS NEGATIVE THREE TIMES OVER A 3 DAY PERIOD ((B)(6) 2021). THE SAMPLE FROM THE 2ND ASYMPTOMATIC "PATIENT" TESTED ON (B)(6) 2021 RESULTED NEGATIVE ON A COMPETITOR ASSAY (CEPHEID), AND THEN RETESTED ON (B)(6) AS POSITIVE ON THE SIMPLEXA ASSAY (CT = 38.3). REPEAT TESTING ON (B)(6) OF THIS SAMPLE ON BOTH THE CEPHEID AND SIMPLEXA ASSAYS RESULTED AS NEGATIVE. ALTHOUGH THE RESULTS WAS REPORTED TO A CLINICIAN OR PATIENT, THE CUSTOMER CONFIRMED PATIENT TREATMENT WAS NOT IMPACTED BY THE FALSE RESULT AND NO ALLEGED HARM OCCURRED. PATIENT INFORMATION AND PATIENT SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON 2 ASYMPTOMATIC PATIENT SAMPLES TESTED ON THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150 LOT# 10127N. PATIENT INFORMATION WAS REQUESTED ON (B)(6) 2021 BUT NO RESPONSE HAS BEEN GIVEN BY THE CUSTOMER AS OF 5/7/2021. THE CUSTOMER HAS NOT RETURNED ANY ISSUE KITS FOR INVESTIGATION NOR HAVE THEY PROVIDED ANY PATIENT SAMPLES FOR TESTING. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# X11575N, 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. RETAIN TESTING HAS BEEN SCHEDULED.

    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 ON (B)(6) 2021 ALLEGING FALSE POSITIVE RESULTS ON 2 ASYMPTOMATIC PATIENT SAMPLES TESTED ON THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150 LOT# 10127N . THE SAMPLE FROM THE 1ST ASYMPTOMATIC PATIENT RESULTED NEGATIVE ON THE INITIAL SIMPLEXA TEST ON (B)(6) 2021, AND THEN RESULTED POSITIVE ON REPEAT TESTING 1 WEEK LATER ON (B)(6) 2021 (CT = 36.4), AND THEN REPEATED AS NEGATIVE THREE TIMES OVER A 3 DAY PERIOD (B)(6) 2021. THE SAMPLE FROM THE 2ND ASYMPTOMATIC PAITIENT TESTED ON (B)(6) 2021 RESULTED NEGATIVE ON A COMPETITOR ASSAY (CEPHEID), AND THEN RETESTED ON (B)(6) AS POSITIVE ON THE SIMPLEXA ASSAY (CT = 38.3). REPEAT TESTING ON (B)(6) OF THIS SAMPLE ON BOTH THE CEPHEID AND SIMPLEXA ASSAYS RESULTED AS NEGATIVE. ALTHOUGH THE RESULTS WAS REPORTED TO A CLINICIAN OR PATIENT, THE CUSTOMER CONFIRMED PATIENT TREATMENT WAS NOT IMPACTED BY THE FALSE RESULT 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
    699573 SIMPLEXA COVD-19 DIRECT ASSAY REAL TIME RT-PCR ASSAY FOR THE IVD QUALITATIVE DETECTION OF SARS-COV-2 VIRAL RNA QJR DIASORIN MOLECULAR LLC 10127N

    Patients

    Seq Age Sex Outcome Treatment
    1