BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 16616245 · Received March 24, 2023

    Report

    Report Number
    2023365-2023-00007
    Event Type
    Malfunction
    Date Received
    March 24, 2023
    Date of Event
    March 16, 2023
    Report Date
    March 24, 2023
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    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 A NO TEMPLATE CONTROL (NTC) SAMPLE WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. RUN ANALYSIS OF THE SIMPLEXA RESULTS ARE AS FOLLOWS: RUN (B)(6) 2023 @ 1027: SAMPLE ID NEG CT: INVALID DUE TO DETECTION OF S GENE (29.7) ORF1AB (30.3) IN ADDITION TO THE DETECTION OF THE NO TEMPLATE CONTROL (NTC), A SAMPLE IN WELL 8 WAS DETECTED [SAMPLE ID (B)(4): S GENE (31.2) ORF1AB (30.9)]. IT IS NOT KNOWN IF THIS WAS A FALSE POSITIVE RESULT SINCE THE CUSTOMER ONLY ALLEGED THE NTC WAS FALSELY DETECTED. QUESTIONS WERE SENT TO THE CUSTOMER ON HOW THE CUSTOMER STORES REAGENTS AND WHAT TRANSPORT MEDIA WAS USED, BUT NO RESPONSE WAS GIVEN. THE CUSTOMER WAS CONTACTED AGAIN ON (B)(6) 2023 IF THEY HAVE HAD ANY OTHER ISSUES WITH FALSE POSTIIVES OR NTC FAILURES SINCE THE INITIAL EVENT AND NO FURTHER OCCURRENCES HAVE HAPPENED. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE NTC SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# 15498N 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. RETAINS OF THE SUSPECTED DEVICE WERE TESTED ON (B)(6) 2023 WITH 14 NTC REPLICATES WITH ZERO (0) OCCURRENCES OF FALSE POSITIVE IN ANY OF THE 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. IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE AND THE ISSUE IS CONSIDERED UNCONFIRMED AT THIS TIME. THIS IS THE 1ST COMPLAINT ON MOL4150 LOT 15506N FOR SUSPECTED FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON A NO TEMPLATE CONTROL (NTC) SAMPLE WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER CONFIRMED NO ALLEGED HARM OCCURRED. ISSUE IS AN NTC FALSE POSITIVE (INVALID RESULT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522555 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 15506N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown