BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 16941072 · Received May 16, 2023

    Report

    Report Number
    2023365-2023-00009
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 16, 2023
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    UDI-DI
    20816101027044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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. THE END USER HAD COMPLAINED OF INSTRUMENT CONTAMINATION EVEN AFTER DECONTAMINATION. A DIASORIN FSE WAS DISPATCHED TO THE CUSTOMER SITE AND ASSISTED WITH THE DECONTAMINATION. SINCE THE FSE VISIT, THE CUSTOMER HAS NO FURTHER ISSUES WITH FALSE POSITIVES. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION, BUT IT APPEARS PROPER DECONTAMINATION HAS RESOVLED THEIR FALSE POSITIVE ISSUE. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# 17702N 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 (B)(6) 2023 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 AND THE ISSUE IS CONSIDERED UNCONFIRMED AT THIS TIME.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON AN ENVIRONMENTAL SWAB SAMPLE WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER CONFIRMED NO ALLEGED HARM OCCURRED. THE FALSE POSITIVES HAVE ONLY OCCURRED ON ENVIRONMENTAL SWABS AND THEY HAVE NOT SEEN INVALIDS OR UNEXPECTEDLY HIGH NUMBERS OF POSITIVES WITH PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734624 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 17632N 20816101027044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown