MAUDE Adverse Event Report: BIOMERIEUX 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
On (b)(6) 2025, a customer from spain notified biomérieux of obtaining an error 20160 when using emag (ref.(b)(4), serial number: (b)(6) leading to delayed result.The customer reported obtaining error 20160 during an extraction run.It was not specified whether this was a punctual or recurring error.Due to this issue, the customer had to repeat the extraction for some samples (number of impacted patients not specified), resulting in a one-day delay in reporting patient results.And for some samples (number of impacted patients not specified), the sample volume was not sufficient to repeat the extraction, so the delay was one to two weeks until a new sample was collected.There is no indication or report from the laboratory that the delayed result led to any adverse event related to patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed following a notification from a customer from spain who obtained a communication error, no.20160, when using emag ref.418591, serial number: (b)(6) leading to delayed result.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.No other recurrence of this issue was reported afterwards.2.Investigation results.The instrument behavior related to the communication error no.20160 can be ascribed to the following two reasons: (1) 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.(2) 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 D): BIOMERIEUX 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: sandra locca-bernard ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 22554993
• Report Number: 9615037-2025-00029
• Device Sequence Number: 9647045
• Product Code: JJH
• UDI-Device Identifier: 03573026471859
• UDI-Public: 03573026471859
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 07/21/2025
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown