BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 17786050 · Received September 20, 2023

    Report

    Report Number
    2023365-2023-00013
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    September 5, 2023
    Report Date
    September 20, 2023
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AN ENVIRONMENTAL SWAB SAMPLE WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. NO RUN FILES HAVE BEEN PROVIDED. SUGGESTIONS WERE MADE TO THE CUSTOMER TO PERFORM SWIPE TESTS TO DETERMINE IF THERE IS CONTAMINATION IN THE LAB, CLEAN THE LAB SPACE, SWITCH PIPETS, TEST NEW UTM, AND USE NEW TIP BOXES. AFTER A COUPLE OF FOLLOW UP ATTEMPTS WITH THE CUSTOMER, THE CUSTOMER STATED THEY NO LONGER WERE GETTING POSITIVE RESULTS WITH THE SAME KIT LOT AFTER CLEANING THE LAB, SWAPPING OUT PIPETS AND PIPET TIP BOXES, AND MADE CHANGES TO THEIR WORK FLOW. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# 17712N 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. THE ASSAY ISSUE IS NOT CONFIRMED AND MOST LIKELY DUE TO THE CONTAMINATION IDENTIFIED AT THE CUSTOMER SITE. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON AN NTC ENVIRONMENTAL SWAB WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. NO ACTUAL PATIENT TESTING WAS PERFORMED. THE CUSTOMER CONFIRMED NO ALLEGED HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585037 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 17694N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown