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

Model Number	418591
Medical Device Problem Code	Short Fill (1575)
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.On (b)(6) 2025, a customer from united states notified biomérieux of an instrument error (liquid level detection issue) when using emag instrument (ref.(b)(4), serial no.(b)(6)) leading to delayed results.From (b)(6) 2025, the customer launched runs with emag instrument and obtained thirty-eight (38) sample¿s runs invalidated by error 14002 ¿ no liquid detected by pipettor during eluate transfer in output tubes.Due to this issue, the customer reported a delay in results > 24 hours.It is to be noted that the number of patients impacted is unknown at the time of this assessment.Based on the available information at the time of this assessment, there was no report of any potential patient¿s impact of this issue.A biomérieux internal investigation will be initiated.

• 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: romain marti ; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• MDR Report Key: 23575894
• Report Number: 9615037-2025-00038
• Device Sequence Number: 18552127
• Product Code: JJH
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 06/29/2026

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: 10/20/2025
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 06/29/2026
• 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