BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12221910 · Received July 23, 2021

    Report

    Report Number
    2023365-2021-00106
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Date of Event
    June 28, 2021
    Report Date
    July 23, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON FIVE (5) PATIENT SAMPLES THAT RESULTED POSITIVE ON (B)(6) 2021 AT 8:17AM WHEN USING THE SIMPLEXA COVID -19 DIRECT ASSAY. RUN ANALYSIS OF THE SIMPLEXA RESULTS SHOWED FIVE (5) PATIENT SAMPLES (B)(6). BASED ON THIS INFORMATION, IT IS LIKELY THE SAMPLES WERE NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY, BUT THE CUSTOMER'S DEVICE AND PATIENT SAMPLES WERE NOT RETURNED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# X11379N, 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 EITHER S GENE OR ORF1AB TARGETS. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING RETAINS WERE TESTED ON (B)(6) 2021 WITH EIGHT (8) NTC REPLICATES AND ZERO (0) FALSE POSITIVES OCCURRED IN EITHER TARGET. NO MALFUNCTIONS OCCURRED. 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. WITHOUT THE CUSTOMER'S DEVICE OR SUSPECTED FALSE POSITIVE SAMPLES, IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. THIS IS THE 2ND COMPLAINT ON MOL4150 LOT# X11284N FOR SUSPECTED FALSE POSITIVES.

    Description of Event or Problem · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON FIVE (5) PATIENT SAMPLES THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID -19 DIRECT ASSAY, BUT RESULTED NEGATIVE UPON REPEAT USING THE SAME ASSAY LOT. THE CUSTOMER CONFIRMED THE SUSPECTED FALSE POSITIVE RESULTS WERE NOT REPORTED TO THE 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
    1118049 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 X11284N

    Patients

    Seq Age Sex Outcome Treatment
    1