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

Model Number	418591
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Issue description: on 23-jul-2024, a customer in france notified biomérieux of an instrument error leading to delayed results when using emag instrument (reference (b)(4) , serial number (b)(6)).The results were delayed for 24 hours because the ic (required to validate a result) was not compliant.Patients were unable to obtain their results until the following day, after a new extraction.The number of patients involved is not known.There is no indication or report from the laboratory that the delayed result led to any adverse event related to the patient's state of health.At the time of this assessment, there was no indication of patient harm or incorrect treatment.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in france regarding an instrument error leading to delayed results when using emag instrument (reference 418591, serial number (b)(6)).The results were delayed for 24 hours because the ic (required to validate a result) was not compliant.Patients were unable to obtain their results until the following day, after a new extraction.The number of patients involved is not known.A biomérieux internal investigation has been completed with the following results: the customer provided biomerieux with the emag reports, estream runs and reports, pcr runs and emag logs to allow a deeper investigation into the customer's issue.- the emag reports and logs analysis showed a good dispense of samples, buffers & ic2 during the runs and didn¿t highlight any issue during extraction runs.- the analysis of shared estream run reports don¿t show any pipetting or distribution issue - on july 31, a test was launched with water and some positive samples on both sections of the customers two emags.This gave good results for ic2 and pcr target using a new fresh tube of ic2.Following this test, a field service engineer (fse) intervention was triggered because of non-accurate eluates volumes on left section of emag (b)(6).- the customer's system was checked on august 16th: elution volume issue was solved by the fse intervention.Note that a smaller elution volume than expected would concentrate the eluate and lead to earlier ct values and not to inhibition.So the eluate volume issue cannot be the root cause of inhibited results observed.No leakage of lysis buffer and/or extraction buffer 1 was observed which could explain the total inhibition of their samples.To summarize, - no other complaint has been recently recorded on cmv, ebv and hsv1&2 vzv r-gene kits for inhibition issue or invalid ic2.- emag and estream reports and logs provided did not highlight any issue.- on july 31, good results were obtained for ic2 on the customer's two (2) emags before fse intervention, when using a new fresh tube of ic2.In conclusion, no performance issues have been detected concerning emag, estream and argene kits.The possible root cause of the issue seems to be a handling issue or an issue with ic2 tube(s) (storage, contamination¿).

• 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): BIOMERIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• Manufacturer Contact: danielle cooper ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 19920177
• Report Number: 9615037-2024-00023
• Device Sequence Number: 8178123
• 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): 09/04/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/04/2024
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown