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.The emag® system is intended for use by laboratory health professionals only.Issue description on 04-sep-2024, a customer in the united kingdom notified biomérieux of an instrument error leading to a delay in patient results when using emag® system reference (b)(4).Serial number (b)(6).According to the run reports, the were 2 distinct errors on the left (lhs) section of the instrument.- error 20143 microstep driver [axis-0] communication failure - error 10065 ab aspiration threshold timeout meaning that unexpected pressure value detected in the aspiration circuit (<-45 kpa), leading to run abortion.The customer has reported that no pcr was completed due to failed extraction, impacting 68 results.The number of impacted patients was not reported.At the time of this assessment, there is no indication of patient harm or incorrect treatment due to the issue.The customer reported a delay (duration unknown).An internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was initiated following notification from a customer in the uk of an instrument error (error 10065 ¿aspiration threshold timeout¿) leading to a delay in patient results when using emag® system reference (b)(4) serial number (b)(6).A field service engineer (fse) was dispatched to the site to inspect the instrument.The problem was reportedly solved by replacing the vacuum pump.However, since the defective pump was not returned for investigation, it has been impossible to provide additional investigation in what happened in this specific case.Despite not having sufficient information, logs or any part to investigate from, we can make the following assumptions regarding the possible root causes of the instrument failure.Wrong aspirator tips loading: this generic error leaves one of the three aspiration lines open to the outside pressure (as is).The instrument is equipped with sensors to command the opening/closing of the respective solenoid valve; however, there is currently no way to discern whether the consumable is wrongly inserted or not.This is one of the main reasons for the occurrence of error no.10065.Cold lb or eb1 buffers: dispensation of cold reagents is often prone to crystallization during the aspiration, and this could lead to aspiration errors (no.10065).Sample quality issue: sample preparation quality is paramount for the emag extraction; therefore, non-homogeneous samples or suspended solids can negatively affect the extraction, leading to error no.10065.Vacuum line issue: defects on the aspiration line or the vacuum subsystem as a whole (leakage, pump failure, etc) are almost certainly responsible for any pressure loss.The presence of vacuum line issues is thoroughly explored when similar cases arise as they represent the main reason for an instrument's pressure loss.Based on the assumptions reported above, together with the fse observations, we can conclude that a defective component of the vacuum line was likely the original root cause of the issue, although it cannot exclude the possibility of a "wrong aspirator tips loading" error that impaired both sections.Based on 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: 20181465
• Report Number: 9615037-2024-00025
• Device Sequence Number: 15544683
• 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): 04/24/2025

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: 09/04/2024
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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