BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 15176107 · Received August 5, 2022

    Report

    Report Number
    2023365-2022-00032
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    July 11, 2022
    Report Date
    August 5, 2022
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DIASORIN MOLECULAR RECEIVED A COMPLAINT ON (B)(6) 2022 ON THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150 LOT# 12909N FOR SUSPECTED FALSE NEGATIVE RESULTS ON AN UNKNOWN NUMBER OF PATIENT SAMPLES THAT WERE POSITIVE ON A RAPID ANTIGEN TEST. THE CUSTOMER STATED THE PATIENT SAMPLES WERE NASOPHARYNGEAL COLLECTED IN COPAN UTM. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE NEGATIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. RUN ANALYSIS OF THE SIMPLEXA FROM 7/11/22 SHOWED 3 DIFFERENT SAMPLES THAT RESULTS NEGATIVE, BUT WITH RELATIVELY LATE/HIGH CTS ON THE INTERNAL CONTROLS: SAMPLE ID 1: IC CT = 32.2. SAMPLE ID 2: IC CT = 38.1. SAMPLE ID GNSD4JF3F2: IC CT = 33.5. THE CUSTOMER HAS NOT INDICATED WHICH SAMPLE IDS WERE THE FALSE NEGATIVE SAMPLES, BUT HIGH/LATE CTS GREATER THAN 32 INDICATE POSSIBLE INHIBITION OF THE PCR REACTION. IT WAS SUGGESTED THE CUSTOMER PULL NEW SAMPLES AND ALSO RUN CONTROLS. THE CUSTOMER WAS CONTACTED ON (B)(6) 2022 AND INFORMED DIASORIN THE ALLEGED FALSE NEGATIVE SAMPLES ONLY CAME UP POSITIVE WITH LATE/HIGH CTS AFTER THEY DILUTED THE SAMPLES 1:10 (DILUTION IS CONSIDERED OFF-LABEL USE). THIS INDICATES THOSE SPECIFIC SAMPLES MOST LIKELY CAUSED PCR INHIBITION. NO FALSE NEGATIVES OCCURRED WITH POSITIVE CONTROLS AND NO FALSE POSITIVES OCCURRED WITH NEGATIVE CONTROLS. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# 12538N 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 ANY OF THE TARGETS AND AN AVG IC CT = 31.3. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. RETAINS OF THE SUSPECTED DEVICE WERE TESTED ON 7/25/22 WITH 14 REPLICATES (2 DISCS OF 7 PC EACH) OF MOL4160 POSITIVE CONTROL. BOTH TIMES THE TARGETS WERE DETECTED ON ALL REPLICATES (S GENE = 26.5, 27.7 / ORF1AB = 26.9, 27.4) . 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. AS PER IFUK.CE.MOL4150, "NEGATIVE RESULTS DO NO 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 EPDEMIOLOGICAL INFORMATION" AND PER THE LIMITATIONS SECTION, ITEM 4, "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 (B)(6) 2022 ON THE SIMPLEXA COVID-19 DIRECT ASSAY MOL4150 LOT# 12909N FOR SUSPECTED FALSE NEGATIVE RESULTS ON AN UNKNOWN NUMBER OF PATIENT SAMPLES THAT WERE POSITIVE ON A RAPID ANTIGEN TEST. THE CUSTOMER CONFIRMED THE SUSPECTED FALSE NEGATIVE RESULTS WERE NOT REPORTED TO THE DIAGNOSING PHYSICIAN OR CLINICIAN DUE TO THE DISCREPANCY WITH THE RETEST ON THE ANTIGEN TEST. NO ALLEGED HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689937 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 12909N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown