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

Catalog Number	418591
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a customer from france notified biomérieux of obtaining an aspiration error (error 10065) when using emag (ref.(b)(4) , serial number: (b)(6) leading to the loss of patient samples.On (b)(6)2024, the customer obtained an error 10065 on the right section of the emag (ref.(b)(4), serial number: (b)(6).Due to this issue, the customer specified the loss of two (2) samples because of the error code.In the case, the two samples correspond to aqueous humor and csf (cerebrospinal fluid) with a very low volume collected.The customer was unable to perform another analysis as the customer had no sample left.The customer returned the test as not performed because the quantity was insufficient.A new sample will therefore have to be collected.To be noted that the customer experienced the same issue (error 10065) on the left section of the emag (ref.(b)(4), serial number: (b)(6) without any patient impact.An fse was dispatch on customer site on (b)(6) 2024.Based on the available information at the time of this assessment, there is no data available regarding a potential patient¿s impact of this issue.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed following a notification from a customer from france who obtained an aspiration error (error 10065) when using emag (ref.(b)(4), serial number: (b)(6)) leading to the loss of patient samples.Following the complaint, the vacuum relief electrovalve has been replaced and the vacuum manifold has been cleaned as an immediate action, the emag instrument was running correctly then.The run was aborted due to aspiration pressure threshold errors.Vacuum tests confirmed a problem at the vacuum management, in particular with the air relief system (ev04, vacuum manifold).The result of field service engineer intervention confirmed the formation of crystals inside the vacuum manifold, making it impossible to continue operating the system normally.This is the direct consequence of foam and mist generated in the instrument¿s waste tank going back into the vacuum system and slowly clogging the manifold, tubes and fittings.The instrument was back up and running as soon as the vacuum system was cleaned from the clog, confirming that no other root cause was responsible for the recorded error code.Biomérieux assessed the risk associated with this issue and determined that the overall risk is irrelevant.Additionally, as part of continuous improvement, a new vacuum tank is available to customer's experiencing clogged vacuum manifold issues and is implemented on new emag instruments.

• 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: sandra locca-bernard ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 18949784
• Report Number: 9615037-2024-00010
• Device Sequence Number: 7906303
• Product Code: JJH
• UDI-Device Identifier: 03573026471859
• UDI-Public: 03573026471859
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/16/2024

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 Catalogue 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: 03/13/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/16/2024
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown