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
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).Issue description on 21-dec-2023, a customer in the united kingdom notified biomérieux of an instrument error (code 10076) leading to delay in results when using emag system reference 418591, serial number (b)(6).The customer reported four (4) failures over three (3) cartridges on the left side of the emag.The failures are error code 10076 (ultrasound reading below threshold).At the time of this assessment, there was no indication of patient harm or incorrect treatment.The customer did indicate delay of ~2 days (48 hours) as the impacted samples needed to be re-prepared.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed following a notification from a customer in the united kingdom of an instrument error (code 10076) leading to delay in results when using emag system reference (b)(4), serial number (b)(6).The analysis of logs and database collected on the customer's emag system allowed the investigators to determine that errors 10076, which occurred the (b)(6) 2023 and (b)(6) 2023, are punctual tips clogging.The clogging is probably due to solid parts coming from samples or aggregate between sample/silica & lysis buffer.As reminder, samples have to be liquid and homogeneous prior to loading on emag and if beads are used during pre-treatment step, the customer must ensure that they are well removed before sample loading on emag.No abnormal values for uss reading have been detected for the others runs and samples provided.Thus, no system / uss failure is suspected.As a result of the investigation, there is no reconsideration of the performance of emag system reference (b)(4).

• 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): 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: 18440133
• Report Number: 9615037-2024-00001
• Device Sequence Number: 20778675
• 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): 02/20/2024

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: 12/21/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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