BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 & FLU A/B DIRECT ASSAY

    MDR report key: 13579325 · Received February 22, 2022

    Report

    Report Number
    2023365-2022-00010
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    January 24, 2022
    Report Date
    February 22, 2022
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 UNKNOWN NUMBER OF PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 & FLU A/B DIRECT ASSAY, BUT WERE CONFIRMED NEGATIVE BY AN UNKNOWN METHOD. THE CUSTOMER HAS NOT PROVIDED ANY ASSAY LOT INFORMATION AFTER SEVERAL ATTEMPTS. IT WAS COMMUNICATED TO THE SUBSIDIARY THAT LATE CTS THAT ARE HIGHER THAN THE TYPICAL 22-32 CT RANGE IS POSSIBLY DUE TO THE SAMPLE BEING NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. THIS WAS COMMUNICATED TO THE CUSTOMER AND THEY WERE SATISFIED WITH THE EXPLANATION. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. NO FURTHER INVESTIGATION CAN BE PERFORMED DUE TO THE LACK OF ASSAY LOT INFORMATION.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON AN UNKNOWN NUMBER OF PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 & FLU A/B DIRECT ASSAY, BUT WERE CONFIRMED NEGATIVE BY AN UNKNOWN METHOD. 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
    161458 SIMPLEXA COVID-19 & FLU A/B DIRECT ASSAY REAL TIME RT-PCR ASSAY FOR THE IVD QUALITATIVE DETECTION OF SARS-COV-2 VIRAL RNA QJR DIASORIN MOLECULAR LLC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown