MAUDE Adverse Event Report: INPECO SA ACCELERATOR A3600; LABORATORY AUTOMATION SYSTEM

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that a tube got stuck in the storage module (srm) waste chute.After having removed the tube, the automation system began to notify tube drop errors.The field service engineer (fse) suspected the sensor may have been contaminated.The fse cleaned the sensor (that is located in the chute), then observed tubes going to waste, in order to verify the issue was resolved.During this time, one tube came down, the foil top became loose, and the contents of the tube splashed the fse in the face.The fse cleaned the eye with water and contacted a medical doctor for advice.The fse was advised to remove contact lenses and clean with saline.According to the information available to date, the fse plans to get tested for infectious diseases.
Additional Manufacturer Narrative
According to inpeco's documentation, the error code 0ffa "tube drop failure" is a red error condition, whom recovery indicates to contact the service assistance, as happened.The fse involved was not wearing appropriate ppe.Inpeco verified the completion of the information provided in the service manual: the "satefy compliance" section already states that in case of potential biohazard exposure it is necessary to follow laboratory safety procedures and guidelines for personal protection, including the use of a gown, mask/visor, vinyl gloves, hand sanitizer or shoe covers, and clinical laboratory safety.Therefore, inpeco does not plan to implement any design change to the device.At the moment, no further information regarding the clinical condition of the fse is available.Inpeco will provide additional details coming from the investigation.
Additional Manufacturer Narrative
According to the information provided by the distributor, the fse has returned to work on (b)(6) 2025.The initial injury was not outwardly severe (flushed eye).The fse consulted a doctor who advised to continue flushing.On sep.23rd, the distributor confirmed that the fse took blood tests, and the results were negative.The "health and safety" department she talked with did not have further instructions for her.The fse has to return in six months for a follow-up.

• Brand Name: ACCELERATOR A3600
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• Manufacturer (Section G): INPECO SPA; via givoletto 15; val della torre, 10040 ; IT 10040
• Manufacturer Contact: eva balzarotti ; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 22953920
• Report Number: 3010825766-2025-00005
• Device Sequence Number: 18256036
• Product Code: JQP
• UDI-Device Identifier: 07640172341001
• UDI-Public: (01)07640172341001(11)201029
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/21/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown