BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 17253036 · Received July 3, 2023

    Report

    Report Number
    2023365-2023-00012
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 6, 2023
    Report Date
    July 3, 2023
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 AN NTC/NEGATIVE CONTROL WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. RUN ANALYSIS OF THE SIMPLEXA RESULTS ARE AS FOLLOWS: RUN 06-06-2023 AT 2150: SAMPLE ID: NEG CTRL: INVALID DUE TO S GENE DETECTED (36.5) A DIFFERENT RUN ON 6/8/23 AT 1600 SHOWED IC FAILURE AND ISV ERRORS. BOTH THE ISSUE RUN AND THIS RUN WERE ON ONE INSTRUMENT (INSTRUMENT ID: LOUISE). TWO OTHER RUNS FROM A DIFFERENT INSTRUMENT (INSTRUMENT ID: THELMA) ON 6/9/23 WERE PROVIDED AND SHOWED NO ERRORS AND NO NTC DETECTIONS. INVESTIGATION INTO THE APPARENT NTC CONTAMINATION IS ONGOING BUT IT APPEARS TO NOT BE ASSAY RELATED WITH THE CLEAN RUNS ON ONE INSTRUMENT BUT ERRORS/NTC DETECTION ON THE OTHER. INVESTIGATION INTO OTHER NON-ASSAY RELATED FACTORS IS ONGOING. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# 17711N 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 6/17/23 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.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON AN NTC/NEGATIVE CONTROL WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. NO PATIENT RESULTS IMPACTED. THE CUSTOMER CONFIRMED NO ALLEGED HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031371 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 17693N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown