BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 13003177 · Received December 14, 2021

    Report

    Report Number
    2023365-2021-00168
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 14, 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 NINE (9) PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT WERE CONFIRMED NEGATIVE BY AN UNKNOWN METHODS. RUN ANALYSIS OF THE SIMPLEXA RESULTS ARE AS FOLLOWS: RUN FROM (B)(6) 2021 @ 1916: - SAMPLE ID (B)(6): ORF1AB (35.2). - SAMPLE ID (B)(6): ORF1AB (34.0). - SAMPLE ID (B)(6): S GENE (34.9) ORF1AB (33.8). - SAMPLE ID (B)(6): S GENE (17.0) ORF1AB (17.0). RUN FROM (B)(6) 2021 @ 2200: - SAMPLE ID (B)(6): S GENE (33.4). - SAMPLE ID (B)(6): S GENE (31.8) ORF1AB (31.6). - SAMPLE ID (B)(6): S GENE (32.1) ORF1AB (33.5). - SAMPLE ID "BETTONTE RIP": ORF1AB (33.1). RUN FROM (B)(6) 2021 @ 1910: - SAMPLE ID (B)(6): S GENE (34.0) ORF1AB (34.0). EIGHT OUT OF THE 9 SAMPLES HAD A S GENE CT RANGE = 31.8-34.9 AND ORF1AB CT RANGE = 31.6-35.2 WHICH IS INDICATIVE OF SAMPLES BEING NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. THE ANALYTICAL SENSITIVITY OF THE SIMPLEXA ASSAY IS DETAILED IN THE IFU AND WAS COMMUNICATED TO THE SUBSIDIARY. SAMPLE ID (B)(6) HAD VERY EARLY CTS LESS THAN 20 WHICH INDICATE A POSSIBLE CONTAMINATION OF THE SAMPLE. AS OF (B)(6) 2021, IT IS NOT KNOWN WHAT OTHER PLATFORMS THE CUSTOMER HAS USED THAT PRODUCED NEGATIVE RESULTS AND IF THESE PLATFORMS DETECT THE SAME S GENE AND ORF1AB TARGETS AS THE SIMPLEXA ASSAY. OTHER QUESTIONS ABOUT ENVIRONMENTAL TESTING, TRANSPORT MEDIA TYPES, AND STORAGE OF THE REAGENTS HAVE NOT YET BEEN ANSWERED. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# X14137N, 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 PREVIOUSLY 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# X14137N FOR SUSPECTED FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON NINE (9) PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT WERE CONFIRMED NEGATIVE BY UNKNOWN METHODS. 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
    1904704 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 X12984N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown