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

Model Number	418591
Medical Device Problem Code	Low Sensing Threshold (2575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On 20-jun-2024, a customer in france notified biomérieux of an instrument error (code 10076) leading to delay in results when using emag instrument (reference 418591, serial number (b)(6)).The customer reported that they observe error code 10076 (ultrasound reading below threshold) randomly.This has led to a four (4) day delay in reporting results for an infectious disease csf sample.The customer has provided run logs to be reviewed by global customer service (gcs).Gcs noted the error 10076 is occurring on position 2 after the last aspiration with the buffer#3 and the uss is reading a volume of 575 l of liquid (instead of 30 l).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 (code 10076) leading to delay in results when using emag instrument (reference 418591, serial number (b)(6)).A biomérieux internal investigation has been completed with the following results: 1.Immediate actions done.The field service engineer (fse), biomerieux representative performed the calibration of the ultrasound sensor (uss) of the left section and found a misalignment.2.Investigation result.The fse found a misalignment of the uss along the y axis compatible with the instrument behavior.The re-alignment of the sensor solved the issue, and it was confirmed with the logs collection performed on the emag two weeks after the calibration, where no uss error was encountered after the fse intervention.In conclusion, the root cause of the erratic uss reading was the incorrect sensor alignment along the y axis due to a uss calibration procedure not completely/properly done by the fse, or due to an accidental external impact on the sensor occurred after the sensor calibration itself.Moreover, it was also verified that the mechanical components on the assembly and the alignment procedure do not present any inherent criticality, concluding that the issue under investigation was an isolated case strictly dependent on the configuration of the instrument under investigation.

• 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: 19633082
• Report Number: 9615037-2024-00021
• Device Sequence Number: 17992077
• 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): 08/15/2024

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: 06/20/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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