BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 15556122 · Received October 6, 2022

    Report

    Report Number
    2023365-2022-00039
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    August 23, 2022
    Report Date
    October 6, 2022
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DIASORIN MOLECULAR RECEIVED A COMPLAINT ON THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150 LOT# X13953N FOR A SUSPECTED FALSE NEGATIVE ON THREE (3) OEQASTA RING TRIAL SAMPLES THAT WERE POSITIVE ON THE CEPHEID GENEXPERT COMPETITOR ASSAY. RUN ANALYSIS WAS PERFORMED AND THE RESULTS ARE AS FOLLOWS: SIMPLEXA RUN (B)(6) 2022 (PICTURE ONLY, NO ELECTRONIC RUN FILE, NO CT VALUES SHOWN): 714541: NEGATIVE, 714542: NEGATIVE, 714543: NEGATIVE, 714544: POSITIVE (S GENE, ORF1AB), 714545: NEGATIVE, CEPHEID GENEXPERT RESULTS, PROBE 1 (714541): E GENE (32.4) N2 (36.4), PROBE 2 (714542): E GENE (32.9) N2 (36.5), PROBE 3 (714543): NOT DETECTED BOTH TARGETS, PROBE 4 (714544): E GENE (24.1) N2 (27.8), PROBE 5 (714545): E GENE (37.0) N2 (40.3), IT IS NOTED THAT THE CEPHEID GENEXPERT (E GENE, N2) HAVE DIFFERENT TARGETS THAN THE SIMPLEXA ASSAY (S GENE, ORF1AB). ALSO, THE GENEXPERT UTILIZES EXTRACTION OF THE SAMPLE WHILE THE SIMPLEXA ASSAY DOES NOT. THROUGH DISCUSSIONS WITH THE CUSTOMER, THE SUBSIDIARY BELIEVES THE SAMPLES MAY HAVE COMPATIBILITY ISSUES WITH THE SIMPLEXA ASSAY. IT IS NOT KNOWN WHAT SAMPLE TYPE OR TRANSPORT MEDIA WAS USED FOR THESE OEQASTA RIN TRIAL SAMPLES. BASED ON THE HIGH/LATE CTS FOR SAMPLES 1, 2, AND 5 IT IS LIKELY THOSE SAMPLES ARE NEAR THE SIMPLEXA ASSAY'S LIMIT OF DETECTION (LOD). THE TYPICAL DETECTION RANGE FOR SIMPLEXA IS 22-32 CTS. SAMPLES 3 (NEGATIVE) AND 4 (POSITIVE) APPEAR TO HAVE BEEN INTERPRETED CORRECTLY BY THE SIMPLEXA ASSAY. AN UPDATE WAS REQUESTED BY TECHNICAL SERVICES ON (B)(6) 2022 DISCUSSIONS BETWEEN THE SUBSIDIARY, CUSTOMER, AND THE QQUASTA RING TRIAL OFFICIALS ARE ONGOING AS OF (B)(6) 2022. DOM: 1/16/2022 EXP: 1/31/2023. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# X14076N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151 LOT# X14076N WAS TESTED USING POSITIVE CONTROLS AND NO-TEMPLATE CONTROLS (NTC). POSITIVE CONTROLS WERE TESTED IN QUADRUPLICATE AND RESULTED IN ZERO (0) OCCURRENCES OF FALSE NEGATIVES IN ANY OF THE COVID-19 TARGETS. ALL POSITIVE CONTROLS WERE DETECTED AT AN AVERAGE CT = 27.7 (S GENE), 27.7 (ORF1AB), AND THE INTERNAL CONTROL AVG CT = 33.5. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. RETAINS OF THE SUSPECTED DEVICE WERE TESTED ON (B)(6) 2022 WITH 14 REPLICATES (2 DISCS OF 7 PC EACH) OF MOL4160 POSITIVE CONTROL. BOTH TIMES THE TARGETS WERE DETECTED ON ALL REPLICATES (S GENE = 25.3, 27.1 / ORF1AB = 25.8, 26.8) . NO FALSE NEGATIVES OCCURRED. NO MALFUNCTIONS OCCURRED. POTENTIAL CAUSES FOR THE FALSE NEGATIVE RESULTS MAY BE AN INSTRUMENT FAILURE OR ERROR, AN OPERATOR ERROR, INCORRECT HANDLING OF REAGENTS DURING TESTING OR STORAGE, OR DEVIATION FROM THE ASSAY PROCEDURE OUTLINED IN THE PACKAGE INSERT. IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. THIS IS THE 3RD COMPLAINT ON MOL4150 LOT# X13953N FOR SUSPECTED FALSE NEGATIVES. AS STATED IN THE INSTRUCTIONS FOR USE, IFUK.EN.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 · 0

    DIASORIN MOLECULAR RECEIVED A COMPLAINT ON THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150 LOT# X13953N FOR A SUSPECTED FALSE NEGATIVE ON THREE (3) OEQASTA RING TRIAL SAMPLES THAT WERE POSITIVE ON THE CUSTOMER'S IN-HOUSE PCR ASSAY. THE CUSTOMER CONFIRMED THE SUSPECTED FALSE NEGATIVE RESULTS WERE NOT REPORTED TO THE DIAGNOSING PHYSICIAN OR CLINICIAN SINCE THESE WERE QEQASTA RING TRIAL SAMPLES ONLY. NO ACTUAL PATIENT TESTING OCCURRED. NO ALLEGED HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560816 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 X13953N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown