BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 13056990 · Received December 21, 2021

    Report

    Report Number
    2023365-2021-00174
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 24, 2021
    Report Date
    December 21, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 ONE (1) PATIENT SAMPLE WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT WERE CONFIRMED NEGATIVE WHEN REPEATED ON A COMPETITOR ASSAY (CEPHEID GENEXPERT). RUN ANALYSIS OF THE SIMPLEXA RESULTS ARE AS FOLLOWS: ON (B)(6) 2021, WEDGE 3 OF 7, SAMPLE ID (B)(6): S GENE (34.5) THE SAMPLE WAS DETECTED WITH CTS ABOVE THE TYPICAL 22-32 CT DETECTABLE RANGE AND DETECTED ONLY 1 OF 2 GENES. THIS INDICATES THE SAMPLE WAS POSSIBLY NEAR THE LIMIT OF DETECTIONS OF THE SIMPLEXA ASSAY. IT IS KNOWN THAT THE COMPETITOR CEPHEID GENEXPERT DETECTS DIFFERENT TARGETS (E GENE, N2) THAN SIMPLEXA (S GENE, ORF1AB) AND UTILIZES EXTRACTED SAMPLES WHILE THE SIMPLEXA ASSAY DOES NOT. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. RETAINS OF THE DISC LOT X10962N WERE TESTED AS A PRECAUTION FOR LEAKAGE AND NO LEAKAGES WERE DETECTED. IT IS LIKELY A SAMPLE SPECIFIC ISSUE ONLY. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# X12545N, 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 4TH COMPLAINT ON MOL4150 LOT# X13657N FOR SUSPECTED FALSE POSITIVES.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS. ONE (1) PATIENT SAMPLE WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT WERE CONFIRMED NEGATIVE WHEN REPEATED ON A COMPETITOR ASSAY (CEPHEID GENEXPERT). 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
    1948939 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 X13657N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown