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

Model Number	418591
Medical Device Problem Code	Low Sensing Threshold (2575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On 10-nov-2025, a customer in united kingdom notified biomérieux of an instrument error (code 10076) leading to delay in results when using emag instrument (reference 418591, serial number (b)(6).The customer reported that they observe error code 10076 (ultrasound reading below threshold) randomly.The customer had two (2) samples aborted.One was a csf sample and the other sample was an eye swab in molecular sample solution (mss).The number of patients involved is not known.Both samples were re-extracted the following day on emag right section.Results were delayed by 24 hours but were reported within two (2) days of receipt of the samples in the laboratory.At the time of this assessment, there was no indication of patient harm or incorrect treatment.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united kingdom regarding an instrument error (code 10076) leading to delay in results when using emag instrument, reference number (b)(4), serial number (b)(6).An investigation was opened following the customer's complaint about aborted samples during emag extraction run.Two samples, a csf and an eye swab were invalidated with ultrasound sensing, uss 10076 error code.This complaint was reported due to delayed results.Samples were re-extracted the next day.The investigation was done based on logs analysis.The errors occurred during the washing step with nuclisens extraction buffer 2 for both samples.It corresponded to a volume higher than expected in the wells, most likely due to bubbles that leaded to uss misreading.Other readings of the emag uss look correct for the other runs without any alarm, and for which the data are available in logs.So, an issue with the uss itself is not retained as a root cause.In conclusion, the investigation was not able to define a root cause.One hypothesis is the possibility of bubbles in the sample leading to misreading.

• 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: 23633165
• Report Number: 9615037-2025-00039
• Device Sequence Number: 13095632
• Product Code: JJH
• UDI-Device Identifier: 03573026471859
• UDI-Public: 03573026471859
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/17/2025

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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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