BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12739408 · Received November 2, 2021

    Report

    Report Number
    2023365-2021-00141
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 5, 2021
    Report Date
    November 2, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 AN TWO (2) UTM SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. CUSTOMER PROVIDED PICTURES OF THE ISSUE REACTION MIX MOL4151, LOT# X12507N THAT WAS SHOWING POSITIVES ON STERILE UTM RUNS. THE CUSTOMER SAID THEY DECONTAMINATED THEIR INSTRUMENT AND LAB AND PERFORMED RUNS OF STERILE UTM AS NTCS ON (B)(6) 2021, BUT 2 OUT OF 8 NTC SAMPLES WERE COMING UP POSITIVE FOR ONE TARGET: WELL 4 UTM RESULT: ORF1AB (CT = 35.0), WELL 8 UTM RESULT: ORF1AB (CT = 32.4). IT IS LIKELY THEIR IS SOME LEVEL OF CONTAMINATION SINCE STERILE UTM IS COMING UP SPORADICALLY POSITIVE. DECONTAMINATION OF THE INSTRUMENT (PER THE INSTRUMENT MANUAL) WAS RECOMMENDED AND FOLLOW UP QUESTIONS WERE SENT ON (B)(6) 2021, BUT NO RESPONSE HAS BEEN PROVIDED AS OF 11/1/21. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE UTM SAMPLES HAVE NOT BEEN PROVIDED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X12507N 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) 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. IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. THIS IS THE 1ST COMPLAINT ON MOL4150, LOT# X12491N FOR SUSPECTED FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON AN TWO (2) UTM SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER CONFIRMED NO PATIENT TESTING WAS PERFORMED AS THESE WERE STERILE UTM SAMPLES USED AS NTCS FOLLOWING DECONTAMINATION OF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632709 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 X12491N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown