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

Model Number ACP

Device Problem Use of Device Problem (1670)

Patient Problem Abrasion (1689)

Event Type  Injury  

Manufacturer Narrative

The customer did not provide any image to better identify in which part of the automation system the technician got injured.The track module is covered with panels and the moving parts behind the panels are covered with protective shields that can be removed only by service personnel.The labeling has been reviewed and it has been considered adequate.The operations manual already instructs the operators not to open or remove safety shields and covers during sample processing or if the automation module is on-line and it warns the operators to use caution when accessing parts of the module normally protected by covers since sharp surfaces can be reached.The investigation will be continued if additional information is received from field.

Event Description

A laboratory technician injured her hand while she was trying to retrieve some sample tubes lost at the storage retrieve module and allegedly fallen under the automation system track.The involved tubes would be capped or sealed so they did not cause any sample spillage.The technician removed the panel and she did not pause the track movement.While she was reaching the area to check for missing sample tubes her hand became lodged and she injured her right index finger (skin abrasion and nail damage).The technician was wearing gloves.At the er, they cleaned the wound and administered a tetanus shot.The xray ruled out any fracture.The injury is monitored for infection.

Manufacturer Narrative

The initial report (3010825766-2021-00001) has been submitted on february 12th, 2021.Inpeco requested additional information to the customer multiple times in order to identify in which part of the automation system the technician got injured and to have an update regarding the technician's health conditions and received medical treatments.The customer has not replied and has not provided the data needed to continue the investigation.With the provided information the event has been evaluated the result of a user error since the technician removed the safety shields and covers while the automation system was on-line disregarding the instructions in the operation manual.The automation system is performing according to the specifications.No further actions are required.The adverse event problem codes (section h6) have been updated.The component code is not filled in since the customer did not provide information about the involved automation system part.

• Brand Name: ACCELERATOR A3600
• Type of Device: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 11322547
• MDR Text Key: 231633835
• Report Number: 3010825766-2021-00001
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 07640172341001
• UDI-Public: (01)07640172341001(11)190628
• Combination Product (y/n): N
• PMA/PMN Number: K121012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ACP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other