BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAG®

    MDR report key: 17914431 · Received October 11, 2023

    Report

    Report Number
    9615037-2023-00013
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Report Date
    January 29, 2024
    Manufacturer
    BIOMÉRIEUX ITALIA S.P.A.
    Product Code
    JJH
    UDI-DI
    03573026471859
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS OPENED FOLLOWING A NOTIFICATION FROM A CUSTOMER IN FRANCE REGARDING A CONTAMINATION LEADING TO A POTENTIAL FALSE RESULT FOR PATIENT SAMPLE WITH EMAG (REF. (B)(4), SERIAL NUMBER (B)(6). THE CONTAMINATION WAS ON EMAG ELUATES WITH 16S SEQUENCING DOWNSTREAM APPLICATION. INVESTIGATION RESULTS: SEVERAL NEGATIVE EXTRACTION CONTROLS WERE PERFORMED DURING A BIOMERIEUX INTERVENTION AT CUSTOMER SITE, AND THE CUSTOMER TESTED THEM WITH THEIR 16S SEQUENCING APPLICATION. OUT OF 18 ELUATES, 10 WERE FOUND POSITIVE IN PCR AND SIX (6) OF THOSE WERE SUBMITTED TO SEQUENCING. FOR FIVE (5) SAMPLES, A BACTERIAL SPECIES WERE IDENTIFIED. SEVERAL ENVIRONMENTAL BACTERIAL SPECIES WERE IDENTIFIED FOR THE FIVE (5) SAMPLES: CUTIBACTERIUM ACNES IN TWO (2) SAMPLES, HALOMONAS MURIALIS, OHARAEIBACTER AND CORYNEBACTERIUM KROPPENSTEDTII. BIOMÉRIEUX ASKED THE CUSTOMER TO DECONTAMINATE THE LAB AND TO PERFORM TESTING FOR DECONTAMINATION, BUT THE CUSTOMER REPORTED NOT HAVING ENOUGH TIME TO DO SO. AS A REMINDER, THE CUSTOMER'S SEQUENCING APPLICATION FOLLOWING EMAG EXTRACTION IS NOT VALIDATED. ADDITIONALLY, THE NUCLISENS EXTRACTION REAGENTS ARE NOT CLAIMED DNA/RNA FREE. WITH NO FURTHER FEEDBACK RECEIVED FROM THE CUSTOMER SITE, NO FURTHER INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 0

    INTENDED USE: THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. ISSUE DESCRIPTION ON 15-SEP-2023, A CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING CONTAMINATION WHEN TESTING WITH EMAG (REF.(B)(4), SERIAL NUMBER (B)(6)). THE CUSTOMER DETECTED CUTIBACTERIUM ACNES IN NEGATIVE EXTRACTION CONTROL. HE TESTED ALSO THREE (3) PATIENT SAMPLES AND HE CONFIRMED THAT THEY WERE NEGATIVE FOR CUTIBACTERIUM ACNES, THUS NO CONTAMINATION IMPACT WITH THE PATIENT SAMPLES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180998 EMAG® EMAG - 418591 JJH BIOMÉRIEUX ITALIA S.P.A. 418591 03573026471859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown