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

Model Number	APTIO AUTOMATION
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens and provided permission to connect to the aptio automation system.Siemens noted the sample tube was out of the carrier and stuck in the tube inspection* module (tim).The customer performed troubleshooting and observed the following errors: gripper close fault during sample tube picking errors, lane 20 rack not detected, and unknown tube type.Siemens dispatched a customer service engineer (cse) to the customer's site.The siemens cse noted the system was unable to initialize due to multiple "z up" failures.The cse inspected the air pressure and determined it was operating within specification.The cse replaced z axis assembly and adjusted the racks and lanes.The system was verified and cycled numerous tubes without issues.The system is performing within specifications.No further evaluation of the system is needed.
Event or Problem Description
The customer contacted siemens to inform that a stat cardiac troponin sample tube (sample id (b)(6)) was missing from the aptio automation system.The sample tube was missing and the customer performed a redraw of the patient sample to perform testing.The customer informed siemens that the sample tube was found 4 hours later after the redraw was performed.There are no known reports of patient intervention or adverse health consequences due to the dropped and missing sample tube.

• Brand Name: APTIO AUTOMATION
• Common Device Name: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 10480057
• Report Number: 2517506-2020-00271
• Device Sequence Number: 19490830
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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: APTIO AUTOMATION
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1