BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12350423 · Received August 20, 2021

    Report

    Report Number
    2023365-2021-00114
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    August 10, 2021
    Report Date
    August 20, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON PATIENT SAMPLES THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID -19 DIRECT ASSAY, BUT RESULTED NEGATIVE UPON REPEAT WITH AN UNKNOWN COMPETITOR ASSAY. NO RUNS WERE PROVIDED FOR ANALYSIS AT THE TIME OF THIS REPORT BUT WERE REQUESTED ON 8/10/2021. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# US12573, 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 OF THE SUSPECTED DEVICE WERE TESTED ON 8/16/2021 WITH 14 NTC REPLICATES WITH ZERO (0) OCCURRENCES OF FALSE POSITIVE IN EITHER THE S GENE OR ORF1AB 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. 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 1ST COMPLAINT ON MOL4150, LOT# US12572 FOR SUSPECTED FALSE POSITIVE RESULTS. THE INVESTIGATION CONCLUSION IS PENDING FURTHER INFORMATION FROM THE CUSTOMER FOLLOWING CLEANING AND TROUBLESHOOTING TIPS PROVIDED ON 8/10/2021.

    Description of Event or Problem · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON PATIENT SAMPLES THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID -19 DIRECT ASSAY, BUT RESULTED NEGATIVE UPON REPEAT WITH AN UNKNOWN COMPETITOR ASSAY. 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
    1249064 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 US12572

    Patients

    Seq Age Sex Outcome Treatment
    1