BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 14553333 · Received May 31, 2022

    Report

    Report Number
    2023365-2022-00024
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    May 4, 2022
    Report Date
    May 31, 2022
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPALINT ALLEGING FALSE POSITIVE RESULTS ON ONE (1) PATIENT SAMPLE WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. RUN ANALYSIS OF THE SIMPLEXA RESULTS ARE AS FOLLOWS: (B)(6) 2022@1213. - SAMPLE ID (B)(6): S GENE (34.2), IC (31.7). (B)(6) 2022@1429 .- SAMPLE ID (B)(6): NOT DETECTED, IC (31.0). BASED ON THIS SAMPLE ONLY DETECTING 1 OF 2 TARGETS AND CTS ABOVE THE TYPICAL 22-32 CT DETECTABLE RANGE, IT IS LIKELY THIS SAMPLE IS NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. THE INTERNAL CONTROL WAS DETECTED WITHIN THE TYPICAL 22-32 CT RANGE SHOWING THE REAGENT IS PERFORMING TO SPECIFICATIONS. DOM: 2/17/22, EXP: 02/2023. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# US14109 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) 2022 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 FOR FALSE POSITIVE ON MOL4150 LOT# US14017.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPALINT ALLEGING FALSE POSITIVE RESULTS ON ONE (1) PATIENT SAMPLE WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER CONFIRMED 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
    328953 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 US14017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown