BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 14806991 · Received June 24, 2022

    Report

    Report Number
    2023365-2022-00027
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    June 9, 2022
    Report Date
    June 24, 2022
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 ONE (1) ASYMPTOMATIC PATIENT SAMPLE WITH THE SIMPLEXA COVID-19 & FLU A/B DIRECT ASSAY, BUT REPEATED AS NEGATIVE ON AN UNKNOWN COMPETITOR ASSAY. RUN FILES HAVE NOT BEEN PROVIDED FOR ANALYSIS AS OF (B)(6) 2022. COMMUNICATIONS WITH THE FIELD APPLICATION SCIENTIST (FAS) AND CUSTOMER REVEALED THEIR ARE 2 SITES FOR THIS CUSTOMER: A HOSPITAL LAB WITH 2 LIAISON MDX INSTRUMENTS AND A REFERENCE LAB WITH 1 LIAISON MDX INSTRUMENT. THE REFERENCE LAB WAS TRAINED BY DIASORIN AND HAS NOT HAD ANY ISSUES OF FALSE POSITIVE OR ENVIRONMENTAL CONTAMINATION. THE HOSPITAL LAB HAD LIMITED TRAINING FROM THE REFERENCE LAB AND WAS NOT TRAINED DIRECTLY BY DIASORIN. IT IS SUSPECTED THE ENVIRONMENTAL CONTAMINATION IS DUE TO THE LAB PRACTICES AT THE HOSPITAL LAB. THE FAS RE-TRAINED THE LEAD TECHNICIAN AT THE HOSPITAL LAB AND THEY HAVE RESUMED COVID TESTING. FOLLOW UP QUESTIONS ON THEIR CURRENT STATUS WITH THE COVID ASSAY WERE SENT ON (B)(6) 2022 BUT NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER AS OF (B)(6) 2022. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# US13052 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 MOL4150 LOT# US12986.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON ONE (1) ASYMPTOMATIC PATIENT SAMPLE WITH THE SIMPLEXA COVID-19 & FLU A/B DIRECT ASSAY, BUT REPEATED AS NEGATIVE ON AN UNKNOWN COMPETITOR ASSAY. THE CUSTOMER CONFIRMED NO ALLEGED HARM OCCURRED. SAMPLE COLLECTION METHOD WAS NOT PROVIDED. ENVIRONMENTAL SWABS ALSO CAME UP POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959043 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 US12986

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown