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

Model Number APTIO AUTOMATION SYSTEM

Device Problem Use of Device Problem (1670)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

An outside the united states (ous) customer contacted siemens to report that multiple patient tubes fell out of the sample tube carrier and landed on the carrier belt of an aptio automation system.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the system.The cse checked the functionality of the decapper module, the input/output module and the centrifuge module.All modules were operational.The cse found that multiple sample tubes had poorly adhered sample tube barcode labels.The cause of the sample tubes falling from the carriers was the poorly adhered sample tube barcode labels.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.

Event Description

Multiple patient sample tubes fell out of the sample tube carrier and landed on the carrier belt of an aptio automation system.The sample tubes were both uncapped and capped.The uncapped sample tubes spilled out onto the carrier belt.The customer did not provide the number of sample tubes, sample identification numbers or test names.There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: APTIO AUTOMATION SYSTEM
• Type of Device: APTIO AUTOMATION SYSTEM
• 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: 15897494
• MDR Text Key: 307892360
• Report Number: 2517506-2022-00329
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/01/2022

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 SYSTEM
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/01/2022
• 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