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

Model Number APTIO AUTOMATION

Device Problem Mechanical Problem (1384)

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

Event Date 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens and provided permission to connect to the aptio automation system.Siemens noted the sample tube was out of the carrier and stuck in the tube inspection* module (tim).The customer performed troubleshooting and observed the following errors: gripper close fault during sample tube picking errors, lane 20 rack not detected, and unknown tube type.Siemens dispatched a customer service engineer (cse) to the customer's site.The siemens cse noted the system was unable to initialize due to multiple "z up" failures.The cse inspected the air pressure and determined it was operating within specification.The cse replaced z axis assembly and adjusted the racks and lanes.The system was verified and cycled numerous tubes without issues.The system is performing within specifications.No further evaluation of the system is needed.

Event Description

The customer contacted siemens to inform that a stat cardiac troponin sample tube (sample id (b)(6)) was missing from the aptio automation system.The sample tube was missing and the customer performed a redraw of the patient sample to perform testing.The customer informed siemens that the sample tube was found 4 hours later after the redraw was performed.There are no known reports of patient intervention or adverse health consequences due to the dropped and missing sample tube.

• Brand Name: APTIO AUTOMATION
• Type of Device: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• Manufacturer (Section G): INPECO S.P.A; via torraccia 26; registration #: 3010825766; novazzano 6883 ; SZ 6883
• Manufacturer Contact: rolando hualpa ; 511 benedict avenue; tarrytown, ny ; 5242963
• MDR Report Key: 10480057
• MDR Text Key: 205366957
• Report Number: 2517506-2020-00271
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2020
• Initial Date FDA Received: 09/01/2020
• 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