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

Model Number	APTIO AUTOMATION
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthcare investigated an internal complaint for the aptio automation storage and retrieval module (srm) that may lead to an incorrect association of test result(s) to a sample id and therefore to an incorrect patient result.The mis-association of test results, or a delay in testing, may occur when all the following conditions occur: the srm module is releasing a sample tube (tube a) just placed into the carrier, another sample tube (tube b) is erroneously not diverted into the srm module buffer, and number 1 and 2 occur within a very narrow timing window of each other.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens healthcare investigated an internal complaint for the aptio automation storage and retrieval module (srm) that may lead to an incorrect association of test result(s) to a sample id and therefore to an incorrect patient result.The mis-association of test results, or a delay in testing, may occur when all the following conditions occur: the srm module is releasing a sample tube (tube a) just placed into the carrier, another sample tube (tube b) is erroneously not diverted into the srm module buffer, and number 1 and 2 occur within a very narrow timing window of each other.An urgent medical device correction (umdc) lasw23-02.A.Us was sent to us customers and an urgent field safety notice (ufsn) lasw23-03.A.Ous was sent to outside the united states (ous) customers in may of 2023.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 that a new version of firmware for the aptio automation storage and retrieval module (srm) will correct the 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
• Manufacturer (Section G): INPECO S.P.A; via givoletto 15; registration #: 3005509212; val della torre (torino), 10040 ; IT 10040
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 16945025
• Report Number: 2517506-2023-00156
• Device Sequence Number: 6376524
• Product Code: CDT
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/17/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2517506-05/17/2023-C
• Patient Sequence Number: 1
• Patient Sex: Unknown