BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12771450 · Received November 8, 2021

    Report

    Report Number
    2023365-2021-00146
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    September 28, 2021
    Report Date
    November 8, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 ENVIRONMENTAL WIPE TESTS AND CAP PROFICIENCY SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE ORIGINAL COMPLAINT WAS ON THE DISC ((B)(4)) BUT LOT INFORMATION ON THE ASSAY WAS NOT KNOWN UNTIL 10/12/2021. NO RUNS HAVE BEEN PROVIDED AS OF (B)(6) 2021. THE CUSTOMER COMMUNICATED THAT THEY ARE GETTING "RANDOM POSITIVES ON BOTH CYCLERS AND THEY ARE SEEING IT WITH NEGATIVE CONTROLS." THE CUSTOMER HAS REQUESTED THE CYCLERS BE SERVICED BECAUSE OF THE POSSIBLE CONTAMINATION DETECTED BY THE WIPE TESTS. IT IS LIKELY THE CUSTOMER'S IS EXPERIENCING SOME LEVEL OF CONTAMINATION THAT IS CAUSING THE FALSE POSITIVE RESULTS. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLES HAVE NOT BEEN RETURNED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# 12511N, 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. 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# 11784N FOR SUSPECTED FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON ENVIRONMENTAL WIPE TESTS AND CAP PROFICIENCY SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER CONFIRMED NO PATIENT RESULTS WERE REPORTED TO A 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
    1662893 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 11784N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown