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

Model Number APTIO AUTOMATION BY SIEMENS

Device Problem Missing Test Results (3267)

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

Event Date 04/04/2023

Event Type  malfunction  

Event Description

The customer experienced a delay in testing stat samples on the aptio automation by siemens.The customer informed siemens that sample tubes are being routed and stored at the reagent storage module (rsm), and samples in the rsm are in a 'pending' state.There are no known reports of patient intervention or adverse health consequences due to the delay in testing stat samples.

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center (ccc).The customer informed siemens that samples are retrieved from the reagent storage module (rsm) and sent to run on the atellica solution analyzers; however, patients' samples return without error and are placed again in the storage module, and the aptio receives a cancellation for the test ordered.Siemens dispatched a customer service engineer (cse) to the customer site.The cse performed troubleshooting and noted that samples had been disposed of in previous days.On (b)(6) 2023, siemens received additional information that errors resulted in samples being disposed of prematurely.Creatinine was incorrectly set up as 1-day disposal (urine parameter) and also assigned to serum creatinine samples.The samples were meant to have a 3-day disposal period but resulted in serum creatinine samples being disposed of two days early.The customer has monitored the rsm daily to check the samples in storage for pending tests.The customer noted that the reported behavior did not cause any discordant results.The customer stated that the reported behavior caused delays in receiving patient results.The customer did not provide additional information, and siemens is investigating the event.

Manufacturer Narrative

Siemens filed the initial mdr 2517506-2023-00143 on 20-apr-2023.Additional information (22-may-2023): siemens evaluated the event and noted the aptio input/output module (apt.0053.09.13); refrigerated storage module (rsm) is receiving and storing samples instead of routing them to the aptio.The investigation confirmed that the aptio is working as designed.The sample is sent to the storage after being returned from the atellica solution analyzers without error, the sample is retrieved from storage to be rerun on the atellica solution analyzers, and the sample is returned without error and stored again in the storage module.The aptio receives a cancellation for all the tests ordered, which means centralink has received the results.Sending the sample to storage is the correct behavior.The aptio automation by siemens works as designed, and no further evaluation is required.Section h6 (investigation findings and investigation conclusions) was updated to reflect the additional information.

• Brand Name: APTIO AUTOMATION BY SIEMENS
• Type of Device: APTIO AUTOMATION BY SIEMENS
• 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: rolando hualpa ; 511 benedict avenue; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 16781386
• MDR Text Key: 314029605
• Report Number: 2517506-2023-00143
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 06/15/2023

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
• Device Operator: Health Professional
• Device Model Number: APTIO AUTOMATION BY SIEMENS
• Device Catalogue Number: 10703031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/15/2023
• 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