MAUDE Adverse Event Report: BIOMÉRIEUX ITALIA S.P.A. EMAG®; EMAG - 418591

Model Number	418591
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: EMAG®
• Common Device Name: EMAG - 418591
• Manufacturer (Section D): BIOMÉRIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer (Section G): BIOMÉRIEUX ITALIA S.P.A.; via di campigliano 58/ loc. p; firenze 50012 ; IT 50012
• Manufacturer Contact: dima amro ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 17914431
• Report Number: 9615037-2023-00013
• Device Sequence Number: 6636591
• Product Code: JJH
• UDI-Device Identifier: 03573026471859
• UDI-Public: 03573026471859
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 418591
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown