BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 14399849 · Received May 13, 2022

    Report

    Report Number
    2023365-2022-00023
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 13, 2022
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPALINT ALLEGING FALSE POSITIVE RESULTS ON AN UNKNOWN NUMBER OF PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT WERE CONFIRMED NEGATIVE BY COMPETITOR ASSAYS, GENEXPERT AND SEEGENE. AS OF B)(6) 2022, NO RUN FILES WERE PROVIDED FOR ANALYSIS. THE CUSTOMER'S ENVIRONMENTAL SWABS ARE COMING UP POSITIVE WITH AMPLICON CONTAMINATION ON BOTH OF THEIR INSTRUMENTS. THE SUBSIDIARY IS WORKING WITH THE CUSTOMER ON DECONTAMINATING THEIR INSTRUMENTS AND LAB SPACE AND ARE AWAITING THE RESULTS OF THE DECONTAMINATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# X13750N 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 B)(6) 2022 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. IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. THIS IS THE 1ST COMPLAINT ON (B)(4) LOT# X13683N FOR SUSPECTED FALSE POSITIVES.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPALINT ALLEGING FALSE POSITIVE RESULTS ON AN UNKNOWN NUMBER OF PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT WERE CONFIRMED NEGATIVE BY COMPETITOR ASSAYS, GENEXPERT AND SEEGENE. THE CUSTOMER CONFIRMED NO ALLEGED HARM OCCURRED. PATIENT HEALTH INFORMATION AND SAMPLE COLLECTION METHOD WAS NOT PROVIDED. THE SUBSIDIARY WORKING WITH THE CUSTOMER STATED ENVIRONMENTAL SWAB TESTS ARE COMING UP POSITIVE WITH AMPLICON CONTAMINATION AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240607 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 X13683N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown