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

Model Number	APTIO
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was dispatched to the customer site.The cse discovered that the xp4 connector at the rsm was melted due to an over-heated wire.The cse replaced the power xp4 cord and installed connectors on the blino and xp4 cords.The cooler temperature was monitored and the cse verified the rsm was operational.The cause of the rsm not working was a damaged connector.This instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The refrigerated storage module (rsm) for an aptio automation system stopped working.The customer stated that samples located in the rsm could not be used for testing, as the rsm not maintaining the proper temperature had affected the sample integrity.The customer stated that two samples needed to be recollected for additional testing, but the customer could not provide the test orders for the patients.There are no known reports of patient intervention or adverse health consequences due to delayed testing.

• 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: 6694269
• Report Number: 2517506-2017-00580
• Device Sequence Number: 1735901
• Product Code: JJE
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Report Date (Section B): 07/07/2017

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1