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

Model Number	APTIO AUTOMATION SYSTEM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2517506-2022-00329
• Device Sequence Number: 15128040
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown