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

Model Number	APTIO AUTOMATION
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens investigated an internal complaint for the aptio automation interface module to the advia centaur xp/xpt analyzers.When a sample tube that is to be processed by the advia centaur xp/xpt is not diverted into the interface module due to a mechanical issue or due to an obstruction, one of the following sample tube(s) that is diverted into the interface module to be processed by the advia centaur xp/xpt may be released from the interface module, flagged with the error code 3160 "sampling not successful" and with test results obtained from another sample tube.There are no known reports of patient intervention or adverse health consequences due to this issue.An urgent medical device correction (umdc) lasw21-01.A.Us was sent to unites states customers and an urgent field safety notice (ufsn) lasw21-01.A.Ous was sent to outside the us (ous) customers in october of 2021.The umdc and ufsn explain the behavior described above and requests customers to follow the instructions of the umdc/ufsn to ensure correct operation of the systems.The umdc and ufsn delineate that a new version of firmware for the aptio automation interface module to the advia centaur xp/xpt system will correct the issue.
Event or Problem Description
Siemens investigated an internal complaint for the aptio automation interface module to the advia centaur xp/xpt analyzers.When a sample tube that is to be processed by the advia centaur xp/xpt is not diverted into the interface module due to a mechanical issue or due to an obstruction, one of the following sample tube(s) that is diverted into the interface module to be processed by the advia centaur xp/xpt may be released from the interface module, flagged with the error code 3160 "sampling not successful" and with test results obtained from another sample tube.There are no known reports of patient intervention or adverse health consequences due to this issue.

• Brand Name: APTIO AUTOMATION
• Common Device Name: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 12598208
• Report Number: 2517506-2021-00278
• Device Sequence Number: 3269684
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K043546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: APTIO AUTOMATION
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2517506-10/08/2021-002-C
• Patient Sequence Number: 1