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

Model Number	418591
Medical Device Problem Code	Defective Component (2292)
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.Issue description: on (b)(6) 2024, a customer in the united states notified biomérieux of an instrument error leading to a delay in results when using emag®reference 418591 serial number (b)(6).The customer reported lysis buffer overflowing on right side of emag, leading them to force shutdown of the instrument.After investigation on site by fse, the issue was found to be related to a weakness of a quick connector on the dispense line, leading to buffer leakage inside the instrument.The instrument was repaired, cleaned, and released for use.At the time of this assessment, there was no indication of patient harm or incorrect treatment.The customer reported a delay >24 hours due to sample testing being delayed due to the issue.The customer did not provide detailed information of the delayed samples or if there were multiple patients' samples.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was initiated following notification from a customer in the united states of an instrument error leading to a delay in results when using emag® reference 418591 serial number (b)(6).The customer reported lysis buffer overflowing on right side of emag, leading them to force shutdown of the instrument.1 ¿ immediate actions performed: all the quick connectors affected by the issue were replaced.The area around the connectors and the instrument was cleared by removing the crystals and wiping the spilled reagents.2 ¿ investigation the probable main root cause of the issue could be the accumulation of crystals generated by microscopic air infiltration around the sealing o-ring leading to reagent leakage combined with aging components.The reagent leaked from at least one of the four quick connectors below the process lane and to the outside of the instrument.After verifying the consumption of spare parts 6206454 - emag fittings kit and 6208600 - process lane connectors (x4), we found that the connectors on emag s/n (b)(6) were never replaced since installation.As a consequence, crystals accumulation over time likely has led to the leakage onset.3 ¿ conclusion the quick connectors have been replaced with a dedicated spare part "6208600 - process lane connectors".According to the emag service documentation for preventive maintenance procedure and pm check list, the fse has to systematically check the 8 quick connectors during the preventive maintenance (pm) and replace them if an issue is noticed.At this stage this strategy is sufficient to mitigate the risk.There is no reconsideration of the performance of emag® reference 418591.

• 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: 19491745
• Report Number: 9615037-2024-00018
• Device Sequence Number: 8785631
• Product Code: JJH
• UDI-Device Identifier: 03573026471859
• UDI-Public: 03573026471859
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/28/2024

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: 05/22/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 06/25/2024
• 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