BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12866062 · Received November 23, 2021

    Report

    Report Number
    2023365-2021-00153
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 27, 2021
    Report Date
    November 23, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 ONE (1) PATIENT SAMPLE THAT RESULTED NEGATIVE WITH THE SIMPLEXA COVD-19 DIRECT ASSAY, BUT RESULTED POSITVE WHEN TESTED ON A COMPETITOR ASSAY (CEPHEID GENEXPERT). RESULTS OF THE COMPETITOR ASSAY WERE PROVIDED BY THE CUSTOMER ON THE SUSPECTED FALSE NEGATIVE SAMPLE ID (B)(6). THE GENEXPERT RESULTS DETECTED THE SAMPLE WITH E GENE CT = 30.5 AND N2 GENE CT = 34.0. IT IS KNOWN THE GENEXPERT HAS DIFFERENT TARGETS (E GENE, N2) THAN THE SIMPLEXA ASSAY (S GENE, ORF1AB). IN ADDITION THE GENEXPERT UTILIZES EXTRACTED SAMPLES WHILE THE SIMPLEXA ASSAY USES DIRECT SAMPLES. BASED ON THE DIFFERENT TARGETS AND CTS GREATER THAN 32, IT IS LIKELY THE SAMPLE IS AT THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. NO OTHER NEGATIVE SAMPLES ON THE SAME RUN WERE SUSPECTED TO BE FALSE NEGATIVE. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE NEGATIVE SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# X12510N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151 LOT# X12510N 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 = 27.8 (S GENE) AND 28.4 (ORF1AB) AND THE INTERNAL CONTROL AVG CT = 32.2. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. RETAINS OF THE SUSPECTED DEVICE WERE TESTED ON 11/18/21 WITH 14 REPLICATES (2 DISCS OF 7 PC EACH) OF MOL4160 POSITIVE CONTROL. BOTH S GENE (AVG CT = 27.2) AND ORF1AB (AVG CT = 28.2) 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# X12492N 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 ONE (1) PATIENT SAMPLE THAT RESULTED NEGATIVE WITH THE SIMPLEXA COVD-19 DIRECT ASSAY, BUT RESULTED POSITVE WHEN TESTED ON A COMPETITOR ASSAY (CEPHEID GENEXPERT). THE CUSTOMER CONFIRMED THE ALLEGED FALSE NEGATIVE RESULTS WERE NOT REPORTED TO THE DIAGNOSING PHYSICIAN DUE TO THE DISCREPANCY WITH THE GENEXPERT POSITIVE RESULT. 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
    1764212 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 X12492N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown