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

Model Number APTIO AUTOMATION

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

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

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens regional support center (rsc).Siemens investigated the aptio automation system log files and observed a recurrence of the error sc002 -priority output racks missing or full.Siemens is investigating the event.

Event Description

The customer informed siemens that two stat sample tubes were placed on the track and circled on the track without being processed.The samples were delivered from the aptio input/output module (iom) to the iom's delivery lane.The customer manually removed the tubes.There are no known reports of patient intervention or adverse health consequences due to the delay in testing sample tubes.

Manufacturer Narrative

Siemens filed the initial mdr 2517506-2020-00378 on 18-dec-2020.Additional information (13-jan-2021): siemens reviewed the information provided and system log files and concluded the following: a missing priority output (po) rack prevented tubes to been placed into the input/output module and caused tubes to circle on the track.The customer was informed of the issue and instructed to ensure that a rack is always available in lane 19.The customer is operational and running with no further issue.No systemic issue was identified.The instrument is performing according to the specifications.No further evaluation of the device was required.Section d4 is updated with the correct catalog number 10713760 and replaces 10703031 section h6 is updated with new adverse event problem codes.

• 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
• MDR Report Key: 11041624
• MDR Text Key: 224445108
• Report Number: 2517506-2020-00378
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

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: 10713760
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1