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

Model Number	418591
Medical Device Problem Code	Failure to Transmit Record (1521)
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 04-jun-2025, a customer in the united states notified biomérieux of an instrument error (error code 20160) leading to a delay in patient results when using emag® system reference (b)(4) serial number (b)(6).The customer reported issues with error 20160: communication failure between heater board and process lane board and 20146: dispense pump micros step driver comm failure on their emag system.Field service engineer (fse) was on site previously for a similar issue in may 2025 and the instrument worked for about a week without issue, but then started happening again.The extraction had to be repeated from 04-jun-2025.All samples impacted were able to be re-tested.The number of impacted samples or impacted patients was not specified.At the time of this assessment, there was no indication of patient harm or incorrect treatment.The customer stated a delay >24 hours due to the issue.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was initiated following a notification from a customer in the united states who obtained a communication error, no.20160 when using emag® system reference (b)(4) serial number (b)(6), leading to a delay in patient results.1.Immediate actions performed.The field service engineer (fse) went on site and verified that the error no.20160 was not related to any hardware problem but likely to be a consequence of a random and isolated communication error with the process lane board; in fact, performing the oq run the instrument was fully operative.2.Investigation results.The instrument behavior related to the communication error no.20160 can be ascribed to the following two reasons: process lane board firmware bug in the communication protocol: regarding this point, a fix is currently being developed and will be released in the upcoming updates.Dirty cable / board connections: it has already been demonstrated that such issue could be caused by crystalized or dirty connections of electronic boards.This is usually related to the fact that the reagent's mist generated during the instrument operation can settle around the heater board connections hindering the communication frequency.A visual check of crystallization is performed during the preventive maintenance.Additionally, the upcoming update will also include an improvement which reduces the temperature reading frequency during the protocol when the heater board is not in use, therefore, reducing the statistical occurrence of the communication error.In conclusion, the root cause of the error no.20160 is already identified, and as part of continuous improvement, a firmware improvement is ongoing to reduce the occurrence of the communication error.

• Brand Name: EMAG®
• Common Device Name: EMAG®
• Manufacturer (Section G): BIOMÉRIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer Contact: matt floretta ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 22197263
• Report Number: 9615037-2025-00026
• Device Sequence Number: 15593993
• Product Code: JJH
• UDI-Device Identifier: 03573026471859
• UDI-Public: 03573026471859
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/19/2025

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: 06/04/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown