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

Model Number	418591
Medical Device Problem Code	High Sensing Threshold (2574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Product description: 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.The emag® system has been validated with biomérieux reagents and applications.Biomérieux is not responsible for the validation of third-party applications and/or third-party commercial kits.The emag® system is intended for use by laboratory health professionals only.Issue description: on 06-aug-2025, a customer from the united states notified biomérieux of obtaining multiple error codes when extracting patient samples with their emag instrument (ref.418591, serial number: (b)(6)).Customer states they are having ultrasound sensor issues error codes 10076,10077, 20253.Customer states the issues are on both sides of the instrument and it has been an ongoing issue but recently it has gotten worse.Customer was instructed to do an extraction buffer 3 (eb3) cleaning run, followed by a water run.They were also told to check the dispense needles and segment connectors for crystallization and check all reagent bottle connections.If it runs eb3 and water run with no errors, then they should continue and run some samples.The customer noted that they perform this run regularly and it always has issues within a run or two after.The customer is experiencing delayed results > 24 hours when these runs fail.The customer confirmed that the discrepant result did not lead to any adverse event related to the patient's state of health.At the time of this assessment, the number of patients involved is not known.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer from the united states regarding multiple error codes when extracting patient samples with their emag instrument (ref.(b)(4), serial number: (b)(6)).A biomérieux internal investigation has been completed with the following results: 1.Immediate actions performed.Both ultrasound sensors were replaced without any improvement of the situation.2.Investigation result : as the replacement and calibration of both uss sensors did not solve the problem, global customer service (gcs) requested the log collection of both of the customer's instruments ((b)(6)).The logs allowed gcs to compare the uss reading of the four (4) sections and the outcome of this log analysis is the following: the performed investigation demonstrated that the same behavior was encountered on both sections of both instruments installed (s/n (b)(6) and s/n (b)(6)); specifically, the logs analysis showed several uss readings out of the threshold limits at several different positions and extraction steps for the same sample types and extraction methods used.For the above reasons the most probable root cause of the reported issue is represented by a handling issue during the sample extraction / sample preparation, leading to foam or bubbles that disrupted the uss reading.

• Brand Name: EMAG®
• Common Device Name: EMAG®
• Manufacturer (Section D): BIOMÉRIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer (Section G): BIOMERIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer Contact: danielle cooper ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 22877529
• Report Number: 9615037-2025-00035
• Device Sequence Number: 10371296
• Product Code: JJH
• UDI-Device Identifier: 03573026471859
• UDI-Public: 03573026471859
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 08/06/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 11/10/2025
• 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