BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 14119518 · Received April 15, 2022

    Report

    Report Number
    2023365-2022-00020
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 24, 2022
    Report Date
    April 15, 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 LLC RECEIVED A COMPLAINT ALLEGING FALSE NEGATIVE RESULTS WITH TWO PATIENT SAMPLES THAT RESULTED NEGATIVE WITH THE SIMPLEXA COVD-19 DIRECT ASSAY MOL4150, BUT REPEATED POSITIVE ON AN UNKNOWN SYSTEM. RUN ANALYSIS OF THE SIMPLEXA RESULTS FROM (B)(6) 2022 AND (B)(6) 2022 ARE AS FOLLOWS: (B)(6) 2022@0818. SAMPLE IDS (B)(6): NOT DETECTED WITH "FALLING FLUORESCENCE CURVES" ON ALL 3 SAMPLES AROUND 27 CTS WITH COPIES/UL GOING BELOW ZERO. IC DETECTED FOR ALL 3 (35.9, 35.0, 33.3). ALL OTHER SAMPLES HAD NO SUDDEN DROP. (B)(6) 2022 @0548. SAMPLE IDS (B)(6): NOT DETECTED WITH "FALLING FLUORESCENCE CURVES" AROUND 27 CTS WITH COPIES/UL GOING BELOW ZERO. SAMPLE IDS (B)(6): NOT DETECTED WITH "FALLING FLUORESCENCE CURVES" AROUND 36 CTS WITH COPIES/UL GOING BELOW ZERO. THE CUSTOMER IS USING AN UN-VALIDATED TRANSPORT MEDIA AND IS ALSO POOLING SAMPLES IN SOME CASES. IT IS NOT KNOWN WHICH OTHER SYSTEM WAS USED TO CONFIRM THE RESULTS AS POSITIVE. THE CUSTOMER'S DEVICE AND SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. ON (B)(6)2022, THE SUBSIDIARY WORKING WITH THE CUSTOMER STATED THE CUSTOMER IS NO LONGER EXPERIENCING "FALLING FLUORESCENCE." 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 3/31/22 WITH 14 REPLICATES (2 DISCS OF 7 PC EACH) OF MOL4160 POSITIVE CONTROL. BOTH TIMES THE TARGETS WERE DETECTED ON ALL REPLICATES (S GENE = 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 1ST 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 LLC RECEIVED A COMPLAINT ALLEGING FALSE NEGATIVE RESULTS WITH TWO PATIENT SAMPLES THAT RESULTED NEGATIVE WITH THE SIMPLEXA COVD-19 DIRECT ASSAY MOL4150, BUT REPEATED POSITIVE ON AN UNKNOWN SYSTEM. THE CUSTOMER CONFIRMED THE ALLEGED FALSE NEGATIVE RESULTS WERE NOT REPORTED. NO ALLEGED HARM OCCURRED. THE PATIENT SAMPLES WERE OROPHARYNGEAL OR NASOPHARYNGEAL SWABS IN "ZHEJIANG VIRAL TRANSPORT MEDIUM" AND SOME WERE EVEN POOLED SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277141 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