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

Model Number	APTIO BY SIEMENS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a customer site visit by siemens personnel, it was observed that the customer was operating an aptio by siemens system attached to atellica sample handler prime sample handler connect (shc) instrument with the protective covers removed.This configuration permits access to tubes that are moving in the shc and over-rides the cover interlocks.Siemens personnel instructed the customer to operate the instrument with the covers in place, in accordance with the operator guide for the aptio by siemens system.The cause of operating an aptio by siemens automation system attached to an atellica sample handler prime sample handler connect (shc) instrument with the covers removed is a use error.The instrument is performing within specifications.No further evaluation of the device is needed.Mdr 2432235-2019-00218 was filed for the same event.
Event or Problem Description
An aptio by siemens system attached to an atellica sample handler prime sample handler connect (shc) instrument was being operated with the protective covers removed.There are no known reports of patient intervention or adverse health consequences due to operating an aptio by siemens system attached to an atellica sample handler prime sample handler connect (shc) instrument with the protective covers removed.

• Brand Name: APTIO BY SIEMENS
• Common Device Name: APTIO BY SIEMENS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8724381
• Report Number: 2517506-2019-00258
• Device Sequence Number: 2523212
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K161954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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 BY SIEMENS
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1