BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12722429 · Received October 29, 2021

    Report

    Report Number
    2023365-2021-00139
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 29, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 UNKNOWN NUMBER OF PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT REPEATED AS NEGATIVE ON COMPETITOR ASSAYS / SYSTEMS (CEPHEID GENEXPERT AND COVID QPCR QUANTSTUDIO 12K FLEX). AS OF 10/29/21, RUN FILES HAVE NOT BEEN PROVIDED BY THE CUSTOMER. RUN ANALYSIS CANNOT BE PERFORMED AT THIS TIME. EMAIL COMMUNICATIONS ON 10/01/21 REVEALED THE CUSTOMER MAY NOT BE CONSISTENTLY STORING THE PARTIALLY USED DISCS FLAT AS "THEY MAY HAVE BEEN TILTED AT ANY GIVE TIME SINCE WE PUT THEM IN THE PACKAGE AND THEN IN A SOMEWHAT HAPHAZARD FASHION STORING THEM IN THE ORIGINAL PRODUCT BOX. FLAT STORAGE WAS NOT SOMETHING THAT WE HAD EMPHASIZED DURING TRAINING." THE CUSTOMER COMMUNICATED THAT ENVIRONMENTAL TESTING WITH SALINE AS AN NTC IS COMING BACK NEGATIVE AND QC TESTING (POSITIVE CONTROL) IS PASSING. THEY HAVE REPEATED THE SUSPECTED FALSE POSITIVE SAMPLES ON 2 DIFFERENT SYSTEMS - CEPHEID GENEXPERT AND COVID QPCR QUANT STUDIO 12K FLEX. IT IS KNOWN THAT THE GENEXPERT UTILIZED EXTRACTED SAMPLES WHILE THE SIMPLEXA ASSAY DOES NOT AND HAS DIFFERENT TARGETS (E GENE, N2) COMPARED TO THE SIMPLEXA (S GENE, ORF1AB). AS FOR THE QUANTSTUDIO SYSTEM, IT WAS NOT MADE CLEAR WHICH ASSAY WAS USED, BUT THIS INSTRUMENT/SOFTWARE ALSO USES EXTRACTED SAMPLES. THE CUSTOMER'S DEVICE, DISCS, AND SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# US12509 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. IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. THIS IS THE 1ST COMPLAINT ON MOL4150, LOT# US12448 FOR SUSPECTED FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON AN UNKNOWN NUMBER OF PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT REPEATED AS NEGATIVE ON COMPETITOR ASSAYS (CEPHEID GENEXPERT AND COVID QPCR QUANTSTUDIO 12K FLEX). 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
    1615436 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 US12448

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown