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

Model Number APTIO AUTOMATION

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

An outside the united states customer contacted siemens to report that four patient sample tubes were delayed for testing on an aptio automation system.The operator of the system manually diverted the samples to an analyzer.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the system.The cse rebooted the aptio automation system, resolving the issue.The cse also confirmed that the divert gates and sensors were working properly.The cause of the samples circling the track and not routing to an analyzer is unknown.The aptio automation system is performing within specifications.No further evaluation of this aptio automation system is needed.

Event Description

Four patient sample tubes were delayed for testing on an aptio automation system.The patient sample tubes circled on the track for several hours before being routed to an advia centaur xp immunoassay system for testing.There are no known reports of patient intervention or adverse health consequences due to the delay in testing.

• Brand Name: APTIO AUTOMATION
• Type of Device: APTIO AUTOMATION
• 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; registration #: 3005509212; 10040 val della torre (torino), ; IT
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 15754179
• MDR Text Key: 305190088
• Report Number: 2517506-2022-00296
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2022

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 AUTOMATION
• Device Catalogue Number: 10703031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/08/2022
• 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