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

Model Number	APTIO AUTOMATION SYSTEM
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens to report that an aptio by siemens automation system put two sample id labels on one tube.Siemens investigated the issue and found the aliquoter module (aqm) had a connection problem while creating a daughter sample tube.There was also an ¿e0cb printer communication failure¿ error.The aqm error takes the aqm offline and requires the operator to take action to recover from the error.During recovery the daughter tube was identified as having two different sample id labels, was removed from the aqm and not tested.The mother tube was returned to the input/output module (iom) and removed by the operator.The cause of the aqm connection problem is unknown but the printer communication error is suspected.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.Mdr 2432235-2024-00108, filed 17-may-2024, and 2432235-2024-00108_s1, filed 07-jun-2024, were submitted for the same event using an incorrect mdr number prefix.
Event or Problem Description
The customer contacted siemens to report that an aptio by siemens automation system put two sample id labels on one tube.The sample ids were from two different patients with sample ids (b)(6).The tube was not processed on the automation system.The customer indicated a new sample was requested for both patients.Repeat testing was performed on alternate samples.There are no reports of injury due to the event.There are no reports that a test result caused a medical procedure to be delay or withheld.There are no reports of harm to patient or operator.

• Brand Name: APTIO AUTOMATION SYSTEM
• Common Device Name: 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) 19714 -610; IT 19714-6101
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10595
• MDR Report Key: 19485887
• Report Number: 2517506-2024-00159
• Device Sequence Number: 7924625
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/07/2024

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): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/07/2024
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown