BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 15936576 · Received December 7, 2022

    Report

    Report Number
    2023365-2022-00041
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    November 13, 2022
    Report Date
    December 7, 2022
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ON (B)(6) 2022 ALLEGING FALSE POSITIVE RESULTS ON TWO (2) PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 FLU A/B DIRECT ASSAY WHICH WERE NEGATIVE ON A COMPETITOR ASSAY ROCHE COBAS LIAT. THE SIMPLEXA RESULTS FROM (B)(6) 2022 WERE ONLY PROVIDED AS A SCREENSHOT AND SHOWED 2 SAMPLES WITH DETECTION IN THE CFR610 (COVID) TARGET WHEN RUNNING THE SIMPLEXA ASSAY. THE SAMPLE IDS WERE NOT COMPLETELY SHOWN IN THE SCREENSHOT, BUT APPEARED TO BE VALID RESULTS. THE CUSTOMER STATED THE TWO POSITIVE RESULTS WERE APPROXIMATELY AT 30 CTS. IT IS NOTED THAT THIS VERSION OF THE ROCHE COBAS ASSAY UTILIZES EXTRACTED SAMPLES AND HAS DIFFERENT TARGETS (ORF1AB, N GENE) THAN THE SIMPLEXA ASSAY (ORF1AB, S GENE). IT IS POSSIBLE THE SIMPLEXA ASSAY DETECTED SOMETHING THE ROCHE COBAS COULD NOT DUE TO DIFFERENT GENE TARGETS & SENSITIVITIES, BUT THE CUSTOMER'S DEVICE AND SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4251 LOT# 16315N 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 (B)(6) 2022 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 AT THIS TIME. THIS IS THE 1ST COMPLAINT FOR FALSE POSITIVE ON MOL4250 LOT# 16314N.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON TWO (2) PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 & FLU A/B DIRECT ASSAY, BUT WAS NEGATIVE ON A COMPETITOR ASSAY ROCHE COBAS LIAT. THE CUSTOMER CONFIRMED THE RESULTS WERE NOT REPORTED TO A PATIENT AND NO ALLEGED HARM OCCURRED. SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136353 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 16314N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown