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

Model Number	ACP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Unspecified Infection (1930); Laceration(s) (1946); Injury (2348)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A sample tube got stuck inside the robot gripper of the rack input module (rim) which is an automation system module which allows the movement of sample tubes from a rack to the automation sample carriers.When the gripper tried to place the tube into the carrier the error on the up-down robot movement was generated and the module stopped working.The error recovery required the intervention on the module and the customer contacted the service assistance.The involved tube was a square base tube which is not allowed on the automation system: the tube was erroneously placed into the rack loaded in the rim by the operator.The field service engineer removed the safety cover and tried to pull the tube out of the gripper.Doing so, he cut his finger with the gripper fingers.He was wearing ppe, including gloves.The cut did not require any medical treatment.A blood test was performed the day after the incident: all test results were negative.The blood tests will be repeated after 1 month, 3 months, 6 months and 12 months.
Additional Manufacturer Narrative
Initial mdr 3010825766-2020-00001 was submitted on january 10th, 2020.New information: the labeling has been reviewed and considered appropriate.The operations manual already specifies which types of sample tubes are allowed on the automation system.In the operations manual and service manual, it has already recommended to use caution when accessing parts of the module normally protected by covers since sharp surfaces can be reached.The field service engineer repeated the blood tests after 1 month, 3 months, 6 months and 12 months.On january 14th, 2021 he confirmed the results were negative for infections.The event has been considered as a human error and no design changes are foreseen.

• Brand Name: ACCELERATOR A3600
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 9575273
• Report Number: 3010825766-2020-00001
• Device Sequence Number: 14097853
• Product Code: CEM
• UDI-Device Identifier: 07640172341001
• UDI-Public: (01)07640172341001(11)180108
• 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): 01/19/2021

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: ACP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1