BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 16445127 · Received February 27, 2023

    Report

    Report Number
    2023365-2023-00002
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    January 31, 2023
    Report Date
    February 27, 2023
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 FOUR (4) PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER DID NOT INDICATE HOW THE SUSPECTED FALSE POSITIVE SAMPLES WERE CONFIRMED NEGATIVE, BUT ADDITIONAL NTC TESTING SHOWED A DETECTION ON 1 OUT OF 5 NTC SAMPLES. RUN FILES BETWEEN (B)(6) 2023 WERE PROVIDED. RUN ANALYSIS OF THE SIMPLEXA RESULTS ARE AS FOLLOWS: RUN (B)(6) 2023 AT 1009: SAMPLE ID (B)(6) (WELL 4): S GENE (32.4) ORF1AB (32.4); SAMPLE ID (B)(6) (WELL 5): S GENE (33.2); SAMPLE ID (B)(6) (WELL 7): S GENE (39.0). PC (WELL 1): ALL TARGETS DETECTED, NTC (WELL 2): NOT DETECTED, ALL OTHER PATIENT SAMPLES NOT DETECTED. RUN (B)(6) 2023 AT 1227: SAMPLE ID (B)(6) (WELL 5): S GENE (33.6). PC (WELLS 1 AND 8): ALL TARGETS DETECTED, NTC (WELL 2): NOT DETECTED, ALL OTHER PATIENT SAMPLES NOT DETECTED. RUN (B)(6) 2023 AT 1339: NTC 5 (WELL 5): S GENE (31.4) ORF1AB (31.2), NTC 1-4 NOT DETECTED. THE LATE CTS ON THE ALLEGED FALSE POSITIVES WERE ABOVE THE TYPICAL 22-32 CT RANGE AND ARE LIKELY NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. WITH THE DETECTION OF 1 OF 5 NTC SAMPLES, IT IS INDICATIVE OF SOME LEVEL OF CONTAMINATION. A DIASORIN APPLICATION SCIENTIST VISITED THE CUSTOMER SITE TO ASSIST WITH DECONTAMINATING THEIR INSTRUMENT AND LABSPACE. THE CUSTOMER'S DEVICE AND ALLEGED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. FOLLOWING THE DECONTAMINATION NO FURTHER ISSUES HAVE OCCURRED. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# 16434N, 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. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. RETAINS OF THE SUSPECTED DEVICE WERE TESTED ON 2/3/23 WITH 14 NTC REPLICATES WITH ZERO (0) OCCURRENCES OF FALSE POSITIVE IN ANY OF THE TARGETS. NO MALFUNCTIONS OCCURRED DURING RETAIN TESTING. ISSUE UNCONFIRMED. POTENTIAL CAUSES FOR FALSE POSITIVE RESULTS MAY BE AN INSTRUMENT FAILURE OR ERROR, AN OPERATOR ERROR, INCORRECT HANDLING OF REAGENTS DURING TESTING OR STORAGE, OR DEVIATION FROM ASSAY PROCEDURES OUTLINED IN THE PACKAGE INSERT. IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. THIS IS THE 1ST COMPLAINT FOR FALSE POSITIVES ON MOL4150 LOT 16428N.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON FOUR (4) PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER DID NOT INDICATE HOW THE SUSPECTED FALSE POSITIVE SAMPLES WERE CONFIRMED NEGATIVE. ALTHOUGH THE POSITIVE RESULTS WERE REPORTED TO A CLINICIAN, THE CUSTOMER CONFIRMED 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
    399049 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 16428N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown