BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12865825 · Received November 23, 2021

    Report

    Report Number
    2023365-2021-00152
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 27, 2021
    Report Date
    November 23, 2021
    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 OF AN UNKNOWN NUMBER OF PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER HAS NOT PROVIDED RUN FILES OR ASSAY LOT INFORMATION AS OF 11/22/21. THE CUSTOMER WAS CONCERNED THE DISCS WERE CAUSING THE ISSUE. RETAINS OF THE SAME DISC LOT 12948N WERE TESTED ON 11/16/21 WITH FIVE (5) DISCS TESTED FOUR TIMES FOR REUSE AND NO LEAKAGES OCCURRED. THE DISC ISSUE IS NOT CONFIRMED. THE ASSAY INVESTIGATION COULD NOT PROCEED AS THERE IS INSUFFICIENT INFORMATION ON THE ASSAY. IT IS LIKELY SOME LEVEL OF CONTAMINATION AT THE CUSTOMER SITE THAT CONTRIBUTED TO THE SUSPECTED FALSE POSITIVE RESULTS. THE CUSTOMER HAS NOT PROVIDED THEIR DEVICE OR SUSPECTED FALSE POSITIVE SAMPLES FOR INVESTIGATION. AT THIS TIME THE FAS IS ASSISTING THE CUSTOMER WITH THEIR DECONTAMINATION PRACTICES AND APPEARS TO HAVE RESOLVED THE OCCURRENCE OF FALSE POSITIVES. WITHOUT THE ASSAY LOT INFORMATION, IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS OF AN UNKNOWN NUMBER OF PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT RESULTED NEGATIVE ON A COMPETITOR ASSAY (FILMARRAY). THE CUSTOMER CONFIRMED NO PATIENT RESULTS WERE REPORTED TO A DIAGNOSING PHYSICIAN OR CLINICIAN. 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
    1764275 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown