BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12741206 · Received November 2, 2021

    Report

    Report Number
    2023365-2021-00142
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 6, 2021
    Report Date
    November 2, 2021
    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 POSITIVE RESULTS ON ONE (1) PATIENT SAMPLE WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT REPEATED AS NEGATIVE ON COMPETITOR ASSAYS (PERKIN ELMER AND QIAGEN). IN ADDITION, PBS NEGATIVE CONTROLS ARE DETECTING ONE OR BOTH TARGETS ON THE SIMPLEXA ASSAY. RUN ANALYSIS OF SIMPLEXA RESULTS WERE AS FOLLOWS: - SAMPLE ID (B)(6), (B)(6) 2021@1722: S GENE (CT = 18.0), ORF1AB (CT = 18.4), EC515 ERROR ON IC (CT = 16.4) INVALID RESULT. - SAMPLE ID (B)(6), (B)(6) 2021@1851: S GENE (CT = 29.1), ORF1AB (CT = 28.9), IC CT = 27.2, POSITIVE RESULT. - SAMPLE ID (B)(6), (B)(6) 2021@2323: S GENE (CT = 25.2), ORF1AB (CT = 25.0), EC515 ERROR ON IC (CT = 23.5) INVALID RESULT. - PBS (AS NTC), (B)(6) 2021@1054 : S GENE (CT = 29.8), ORF1AB (CT = 31.6), IC CT = 29.4, POSITIVE RESULT. - NEG KO (?), (B)(6) 2021@2127: ORF1AB (CT = 33.7). 10/8/21@2129: S GENE (CT = 33.4), ORF1AB (CT = 35.1). - POS KO (?), (B)(6) 2021@2127: NEGATIVE, 10/8/21@2129: NEGATIVE. THE COMPETITOR ASSAYS (PERKIN ELMER AND QIAGEN) RESULTED NEGATIVE WITH THE SAME PATIENT SAMPLE. THE CUSTOMER IS KNOWINGLY USING PBS AS A TRANSPORT MEDIA WHICH HAS SHOWN TO BE INCOMPATIBLE WITH THE SIMPLEXA ASSAY. IT IS NOT KNOWN IF PBS IS COMPATIBLE WITH THE COMPETITOR ASSAYS. IT IS NOT KNOWN WHICH TRANSPORT MEDIA WAS USED TO COLLECT THE PATIENT SAMPLE, BUT BASED ON THE 3 DIFFERENT RUNS WITH 2 OUT OF 3 BEING INVALID, AND THE 1 POSITIVE HAVING "STRANGE CURVES", IT IS POSSIBLE THEY ARE USING PBS SINCE THE PBS ITSELF WAS DETECTED (AS A NTC) FOR ALL TARGETS WITH SIMILAR CTS ON (B)(6) 2021. THE SAMPLE IDS LABELED "NEG KO" WERE DETECTED AND "POS KO" WERE NOT DETECTED, WHICH FURTHER SUPPORTS THE POTENTIAL ROOT CAUSE AS THE PBS. IT WAS RECOMMENDED TO FOLLOW THE IFU RECOMMENDATIONS WITH TRANSPORT MEDIA ON (B)(6) 2021, BUT THE CUSTOMER CONTINUES TO USE PBS. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X13089N 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 EITHER S GENE OR ORF1AB TARGETS. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. IT IS LIKELY THAT THE PBS IS CAUSING THE ISSUE AND THE ISSUE IS CONSIDERED NOT CONFIRMED. THIS IS THE 1ST COMPLAINT ON MOL4150 LOT# X13088N FOR SUSPECTED FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON ONE (1) PATIENT SAMPLE WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT REPEATED AS NEGATIVE ON COMPETITOR ASSAYS (PERKIN ELMER AND QIAGEN). IN ADDITION, PBS NEGATIVE CONTROLS ARE DETECTING ONE OR BOTH TARGETS ON THE SIMPLEXA ASSAY. THE CUSTOMER CONFIRMED NO PATIENT RESULTS WERE REPORTED TO A DIAGNOSING PHYSICIAN OR CLINICIAN. NO ALLEGED HARM OCCURRED. PATIENT HEALTH INFORMATION AND SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632833 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 X13088N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown