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

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The laboratory supervisor notified the field service engineer (fse) onsite that, on (b)(6) 2024 around 6:30 pm, one of the technicians had his finger jammed inside the robot gripper fingers of the centrifuge module (cm), while attempting to manually remove a tube that was stuck inside the gripper due to a barcode label issue.
Additional Manufacturer Narrative
The customer confirmed that the injured laboratory operator had fractured a left finger.He/she went to e.D.For examination: x-ray done to assess the nature of the fracture.A follow-up visit on x-ray was planned.The customer confirmed that the injured laboratory technician was wearing ppe (gloves and lab coat) at the time of incident.No blood analysis performed at the e.D.The customer then specified that, at the time of incident, the laboratory technician was actually trying to remove a cap stuck inside the robot gripper, not the tube as previously indicated.According to the log analysis, there was a tube inside the robot gripper of the centrifuge module (cm).As the laboratory operator had to recover the error, he / she placed the cm offline, and gave diagnostic command "move tube to destination/to source".However, the operation could not be completed, and cm returned again an error.Then the operator opened the safety shield cover, and gave the command to open the gripper.However, the diagnostic command did not work, because the module was powered-off, as the safety shield cover was open.The operator gave the same command 3 more times, getting the same result.Lastly, the operator pull the tube, injuring himself / herself, successfully removing the tube from the gripper.Once the cm was placed back online, it returned an error again.The injury was caused by incorrect procedure followed by the laboratory operator, that should not have manually removed the tube/cap.No device deficiencies were found.Therefore, no actions are foreseen to be taken by the manufacturer.

• 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: 18958703
• Report Number: 3010825766-2024-00002
• Device Sequence Number: 19952977
• Product Code: CEM
• UDI-Device Identifier: 07640172341001
• UDI-Public: (01)07640172341001(11)190628
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

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: 02/22/2024
• Initial Report FDA Received Date: 03/22/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown