MAUDE Adverse Event Report: BIOMÉRIEUX 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)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use.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).Description of the issue.On 22-nov-2023, a customer in belgium notified biomérieux of a delay in rendering the result due to a run abortion during nucleic acid extraction when using emag® (ref.(b)(4), serial number: (b)(6).The customer launched a nucleic acid extraction on 22-nov-2023 from twenty four (24) samples.During the run, an issue occurred that triggered the error code 20160 leading to the run abortion.Among the 24 samples, one was totally lost during the incident leading to a delay because a new sampling has to be made.At this time of the assessment, the length of the delay is not known.There is no indication or report from the laboratory that the issue led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
Context *************** a customer in belgium notified biomérieux of a delay in rendering the result due to a run abortion during nucleic acid extraction when using emag® (ref.(b)(4), serial number: (b)(6)).The instrument error 20160 was solved remotely.Following the customer service recommendation, the system was reinitialized.The reinitialization resolved the issue, and the system was operational.Investigation ***************** - complaint analysis the complaint analysis did not reveal this issue as a systemic quality issue.- test performed the root cause of error 20160 can be traced back to a faulty i2c communication between the heater board and the process lane board, causing a loss of communication.Previous investigations showed how the fault rate, usually extremely low in normal conditions, can be greatly increased in the case of a very dirty instrument due to heavy or incorrect use, or even due to environmental conditions.In the present case, there was a single occurrence on this emag system, and the issue was easily solved by reinitialization of the instrument.No further investigation is needed.If the customer issue recurs, a field service engineer will go on site to check the heater and process lane board connectors as well as the corresponding cables.Conclusion ******************* investigation concluded that no further technical investigation is required as the issue is known and represents a single occurrence on this emag system; indeed, the issue has been easily solved by reinitialization of the instrument.Biomérieux assessed the risk associated with this issue and determined that the overall risk is irrelevant.Additionally, as part of continuous improvement of our product, the 20160 error will be addressed in the next firmware version.

• 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: romain marti ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 18235747
• Report Number: 9615037-2023-00016
• Device Sequence Number: 7160023
• Product Code: JJH
• UDI-Device Identifier: 03573026471859
• UDI-Public: 03573026471859
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/10/2024

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: 11/22/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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