BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 16940637 · Received May 16, 2023

    Report

    Report Number
    2023365-2023-00008
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    April 17, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ON(B)(6) 2023 ALLEGING FALSE POSITIVE RESULTS ON AN ENVIRONMENTAL SWAB SAMPLE WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. NO RUN FILES WERE PROVIDED FOR ANALYSIS. THE CUSTOMER INFORMED THE DSM REPRESENTATIVE OF THAT REGION THAT THEY HAVE RESOLVED THEIR CONTAMINATION ISSUES ON THEIR OWN BY DECONTAMINATING THEIR INSTRUMENT. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. KIT LOT INFORMATION WAS FINALLY PROVIDED BY THE CUSTOMER ON (B)(6) 2023. AS OF (B)(6) 2023, THE INVESTIGATION CONCLUSION IS PENDING THE COMPLETION OF RETAIN TESTING. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# 17707N 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.

    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. NO PATIENT TESTING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638193 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 17642N 20816101027044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown