BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12701211 · Received October 26, 2021

    Report

    Report Number
    2023365-2021-00137
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 28, 2021
    Report Date
    October 26, 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, NEGATIVE CONTROLS, AND CAP PROFICIENCY SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. AS OF 10/25/21, NO SIMPLEXA RUN FILES WERE PROVIDED FOR ANALYSIS. THE CUSTOMER STATING THAT POSITIVES ARE OCCURRING ON ENVIRONMENTAL WIPE TESTS AND NEGATIVE CONTROLS INDICATES SOME LEVEL OF CONTAMINATION AT THE CUSTOMER SITE. CONTAMINATION TROUBLESHOOTING IS STILL ONGOING WITH THIS CUSTOMER AT THIS TIME. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# US13318 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 10/02/21 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# US13314 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, NEGATIVE CONTROLS, AND CAP SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER CONFIRMED THE SUSPECTED FALSE POSITIVE RESULTS WERE NOT PATIENT SAMPLES AS THEY WERE TESTING ENVIRONMENTAL SWABS, NEGATIVE CONTROLS, AND CAP PROFICIENCY SAMPLES ONLY. NO RESULTS WERE REPORTED TO A DIAGNOSING PHYSICIAN OR CLINICIAN. NO ALLEGED HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599770 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 US13314

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown