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)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, a customer in united kingdom notified biomérieux of sample processing abortion leading to no result and delayed results when using the emag® (ref.418591, serial number: (b)(4)) with a patient sample.During the extraction process, the error code 20160 occurred.The customer specified that this error has caused the loss of a mycobacteria sample, which he cannot repeat.It has to be re-grown, which can take weeks.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 will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed following notification from a customer in united kingdom of sample processing abortion leading to no result and delayed results when using the emag® (ref.(b)(4), serial number: (b)(6)) with a patient sample.The root cause of this error can be traced back to a faulty i2c communication between the heater board and the process lane board, causing a loss of communication.Moreover, in previous investigation, it was shown 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 this case, indeed, the cables and the connectors on the boards can show up evident signs of oxidation (or even corrosion) that increase the impedance on the communication lines, therefore, ending up with a seldom corrupted communication (hence, the 20160 error).The intervention that can solve such an issue has been identified and documented and it consists of cleaning the connection surfaces by disconnecting and reconnecting cables multiple times, ensuring that the clean metals are in contact and no additional impedance is generated on the line by the metallic oxides.This behavior is well documented in the ¿emag ¿ troubleshooting guide¿.In the current case, the heater board and the cable were replaced by the field service engineer definitively fixing the problem at the customer site.No error re-occurrence was recorded by the laboratory.Nevertheless, the heater board was tested at biomérieux firenze manufacturing site to see if the problem could be related to the board hardware as it already happened in the past.Since in this specific case, the heater board was perfectly functional, a hardware failure was ruled out and the root cause can be traced back to the dirty board/cable connection.

• 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 ; 5 rue des aqueducs; craponne 69290
• MDR Report Key: 16436751
• Report Number: 9615037-2023-00003
• Device Sequence Number: 14234591
• 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): 05/30/2023

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: 02/16/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 05/30/2023
• 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