MAUDE Adverse Event Report: INPECO SA APTIO AUTOMATION; LABORATORY AUTOMATION SYSTEM

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event has been investigated by the distributor service assistance.Between 20:41:46 and 20:47:19 there were 38 samples that were returned from cm (node 7) without completing their spin cycle into the third-party centrifuge.At 20:24:13 the spin cycle began.Almost immediately the third-party centrifuge produced an error which was mapped by the automation system with the generic error code 2b91 - generic centrifuge error.The error recovery on the automation system interface is the following: "the centrifuge is reporting an internal error.Access the [diagnostics - centrifuge, balance and bucket] screen.Set the centrifuge module .Check the error reported on the centrifuge display and refer to centrifuge operation manual to resolve the issue.Press the function button.Set the centrifuge module back .If the problem persists, contact the service assistance." to restore the proper functioning of the centrifuge, the recovery had to be followed on the third-party centrifuge panel.When the inpeco centrifuge module was put back online, it proceeded to return the sample tubes to the track considering them spun in accordance with the information received from the third-party centrifuge.The event seems to have been caused by an incorrect recovery performed on the centrifuge.Up to now, it has not been possible to check what happened during the recovery and to verify if the sample tubes were actually spun or not.
Event or Problem Description
The customer reported that they observed an issue with the centrifuge module (cm3, node 7) of their aptio automation system.The centrifuge module is the interface which connects the track to the centrifuge (third-party product).According to the customer multiple samples went to cm3, left the module without being spun and were sent to a third-party instrument (atellica) for the analysis.Some of the incorrect results were reported to the physician(s).No specific information about the performed tests and the obtained results have been provided.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
The initial report 3010825766-2025-00004 was sent on august 6th, 2025.Additional information: according to the investigation the error produced by the third party centrifuge was "imbalance error".The centrifuge operations manual requires to "repeat the centrifugation run".The automation system correctly considered the sample tubes as centrifuged.The event is the result of a user error.No performance issue on the inpeco automation system has been identified.No additional actions are foreseen from inpeco side.

• Brand Name: APTIO AUTOMATION
• 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: 22727328
• Report Number: 3010825766-2025-00004
• Device Sequence Number: 15525797
• Product Code: JQP
• UDI-Device Identifier: 07640172342008
• UDI-Public: (01)07640172342008(11)210201
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/19/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (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