BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 13197659 · Received January 7, 2022

    Report

    Report Number
    2023365-2021-00178
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 15, 2021
    Report Date
    January 7, 2022
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE NEGATIVE RESULTS WITH TWO KNOWN POSITIVE EQAS SAMPLES THAT RESULTED NEGATIVE WITH THE SIMPLEXA COVD-19 DIRECT ASSAY, BUT RESULTED POSITIVE WHEN TESTED ON COMPETITOR ASSAYS (CEPHEID GENEXPERT). RUN ANALYSIS OF THE SIMPLEXA RESULTS ARE AS FOLLOWS: (B)(6) 2021, SAMPLE ID 2104161125: NOT DETECTED. (B)(6) 2021, SAMPLE ID 2110181038: NOT DETECTED. POSITIVE CONTROL MOL4160 LOT# X13549N WAS DETECTED FOR BOTH S GENE (25.9) AND ORF1AB (26.6). ACCORDING TO THE EQAS REPORT (IN FRENCH) FROM (B)(6) 2021 PROVIDED BY THE CUSTOMER, THE SAMPLES WERE LYOPHILIZED AND STORED AT 2-8 C AND THEN RECONSTITUTED IN 2ML OF DISTILLED WATER. IT IS NOT KNOWN WHAT SOURCE THE SAMPLES WERE FROM BUT IT IS KNOWN THAT DISTILLED WATER IS NOT A RECOMMENDED TRANSPORT MEDIA TYPE. WITH THE DETECTION OF THE SIMPLEXA POSTIIVE CONTROL WITH THE RUN ON (B)(6) 2021, IT SHOWS THAT THE ASSAY REAGENT IS WORKING. IT IS LIKELY THE SAMPLES THEMSELVES ARE CAUSING THE FALSE NEGATIVES AS THEY WERE FIRST LYOPHILIZED, STORED FOR AN UNKNOWN AMOUNT OF TIME REFRIGERATED, AND THEN RECONSTITUTED IN DISTILLED WATER WHICH IS NOT ONE OF THE RECOMMENDED TRANSPORT MEDIAS LISTED IN IFUK.EN.MOL4150. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE EQAS SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# X13093N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151 LOT# X13093N 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 = 27.2 (S GENE) AND 28.4 (ORF1AB) AND THE INTERNAL CONTROL AVG CT = 31.7. 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 S GENE (AVG CT = 27.1, 27.7) AND ORF1AB (AVG CT = 27.5, 28.1) WERE DETECTED ON ALL REPLICATES. 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 1ST COMPLAINT ON MOL4150 LOT# X13092N 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 · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE NEGATIVE RESULTS WITH TWO KNOWN POSITIVE EQAS SAMPLES THAT RESULTED NEGATIVE WITH THE SIMPLEXA COVD-19 DIRECT ASSAY, BUT RESULTED POSITVE WHEN TESTED ON COMPETITOR ASSAYS (CEPHEID GENEXPERT). THE CUSTOMER CONFIRMED THE ALLEGED FALSE NEGATIVE RESULTS WERE ON EQAS SAMPLES (EVALUATION) NOT ACTUAL PATIENT SAMPLES. NO ALLEGED HARM OCCURRED. EQAS SAMPLES ARE LYOPHILIZED, STORED AT 2-8 DEGREES C AND RECONSTITUTED IN DISTILLED WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943372 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 X13092N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown