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

Model Number	APTIO
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was dispatched to the customer site.The cse adjusted the tension to the track belt, adjusted the belt, and checked all polycords, after which the aptio automation system was operational.The cause of the dropped sample tubes is unknown.The ccc specialist followed up with the customer and the customer stated that he believed some patients were redrawn, but did not have specific information.The customer had not documented which samples fell onto the floor and did not know if any patient care had been affected.This instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The operator of an aptio automation system discovered approximately 10-15 sample tubes which had dropped onto the floor.The customer contacted the siemens customer care center (ccc), but did not provide any additional information.There are no known reports of patient intervention or adverse health consequences due to potential delayed testing.
Additional Manufacturer Narrative
The initial mdr 2517506-2017-00582 was filed on july 10, 2017.Additional information (07/13/2017): a siemens headquarters support center (hsc) specialist reviewed the event and instrument service data and determined that the air pressure to the gripper was low.The hsc specialist also determined that bar code labels which extended over the bottom of sample tubes had prevented proper insertion into the carrier.The gripper was replaced, air pressure was increased, and speed was adjusted in accordance with the alignment procedure.

• Brand Name: APTIO
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 6698422
• Report Number: 2517506-2017-00582
• Device Sequence Number: 985175
• Product Code: JJE
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1