BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12170248 · Received July 14, 2021

    Report

    Report Number
    2023365-2021-00100
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 21, 2021
    Report Date
    July 14, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON PATIENT SAMPLES THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY. RUN ANALYSIS OF THE SIMPLEXA RESULTS FROM MOL4151 LOT# X11379N SHOWED FOUR DIFFERENT SAMPLES THAT RESULTED POSITIVE AS FOLLOWS: SAMPLE ID (B)(6): POSITIVE S GENE (CT = 34.8); SAMPLE ID (B)(6): POSITIVE S GENE (CT = 32.2), ORF1AB (CT = 38.3); SAMPLE ID (B)(6): POSITIVE S GENE (CT = 31.5), ORF1AB (CT = 32.7); SAMPLE ID (B)(6): POSITIVE S GENE (CT = 34.5), ORF1AB (CT = 33.2). AT THIS TIME, THE CUSTOMER HAS NOT COMMUNICATED WHICH OF THESE POSITIVE SAMPLES ARE SUSPECTED FALSE POSITIVES. AN EMAIL WAS SENT 7/9/2021 REQUESTING THIS INFORMATION, BUT THE COMPANY REPRESENTATIVE IN CONTACT WITH THIS CUSTOMER HAS NOT YET RESPONDED. IT IS NOTED THAT 3 OUT OF THE 4 POSITIVE SAMPLES SHOWED LATE DETECTION WITH CTS GREATER THAN 32 WHICH INDICATES THESE SAMPLES ARE LIKELY NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. SAMPLE -3801 ONLY DETECTED THE S GENE AS WELL. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# X11379N, 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 RETAINS WERE TESTED ON (B)(6) 2021 WITH EIGHT (8) NTC REPLICATES AND ZERO (0) FALSE POSITIVES OCCURRED IN EITHER TARGET. NO MALFUNCTIONS OCCURRED. 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. WITHOUT THE CUSTOMER'S DEVICE OR SUSPECTED FALSE POSITIVE SAMPLES, IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON PATIENT SAMPLES THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY. IT IS NOT KNOWN IF ANOTHER METHOD WAS USED TO DETERMINE THE POSITIVE RESULTS WERE INCORRECT. EVEN AFTER INSTRUMENT DECONTAMINATION, THE CUSTOMER STILL SUSPECTS FALSE POSITIVES ARE OCCURRING. THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULTS WERE NOT REPORTED TO A DIAGNOSING PHYSICIAN AND NO ALLEGED HARM OCCURRED. OTHER THAN THE PATIENT SAMPLE IDS, OTHER PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067455 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 X11284N

    Patients

    Seq Age Sex Outcome Treatment
    1