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

Model Number APTIO BY SIEMENS

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2019

Event Type  malfunction  

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 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
• Type of Device: APTIO BY SIEMENS
• 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; italy registration #: 30055092; 10040 val della torre (torino), ; IT
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 8724381
• MDR Text Key: 151191699
• Report Number: 2517506-2019-00258
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K161954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: APTIO BY SIEMENS
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/21/2019
• 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