MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. APTIO AUTOMATION

Model Number APTIO AUTOMATION

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens dispatched a customer service engineer (cse) to the customer site.The cse reviewed the system and observed input/output module (iom) identification (id) errors with the tube identification module (tim); the robot randomly dropped sample tubes and a damaged safety shield.The cse adjusted z axis air pressure, main gauge to 5.0 bar, speed control to be within normal specifications, and tested the aptio automation system.Tubes were loaded and processed with no issue.The cse disabled the tube vision system, and the tim (computer and software), iom (gripper), and safety shield (rear cover) were serviced and replaced.The system was tested, and no issues were noted.The system was tested to run with barcode scan only and was operational.The cse enabled the vision system and loaded tubes to verify the system's performance, and no issues were noted.Siemens reviewed the event, and the customer informed that there were no injuries to any laboratory personnel.The customer informed siemens that no one slipped, tripped, or fell due to the dropped sample tubes and leak.The customer was wearing personal protective equipment (ppe) to clean the leak and was not exposed to any bio-hazardous material.Siemens concluded that the potential cause for the safety shield to become damaged is due to the customer not following operator guide instructions for opening and closing the cover, causing damage and wear to the hinges.Siemens identified no systemic issue with the aptio automation system.The system is operating as intended.No further evaluation of the device is required.

Event Description

The customer informed siemens that the rear cover safety shield on the aptio automation system input/output module had been broken and tampered with glue.Siemens reviewed the information provided and noted the safety shield had some hinges that were missing, re-glued, and broken.Siemens informed the customer that a new cover was required before operating the system due to the potential exposure and hazard of moving mechanical parts.It is unknown if the customer has operated the system without a cover.There are no known reports of patient intervention or adverse health consequences due to the broken safety shield.

• Brand Name: APTIO AUTOMATION
• Type of Device: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): INPECO S.P.A; via givoletto 15; registration #: 3005509212; val della torre, torino 10040 ; IT 10040
• Manufacturer Contact: rolando hualpa ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 12374514
• MDR Text Key: 268426569
• Report Number: 2517506-2021-00234
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2021

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
• Device Operator: Health Professional
• Device Model Number: APTIO AUTOMATION
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1