MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA DIRECT LOAD

Model Number	ATELLICA DIRECT LOAD
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) and noted that their atellica direct load (dl) instrument randomly stops aspirating quality control (qc) and patient samples, can skips a whole panel, or miss one or more assays from the same sample.The customer has restarted the instrument, reprinted barcodes, used different racks, and performed a manually loaded, but the issue randomly recurs, and their turnaround time is affected.Siemens is investigating the event.
Event or Problem Description
The customer informed siemens that their atellica direct load (dl) instrument randomly stopped the aspiration of quality control (qc) and patient samples.The customer noted the behavior caused a delay in patient sample processing, and the physician(s) called requesting patient results.The customer indicated that troubleshooting was performed, which included a system reboot and reloading samples, and the issue is temporarily resolved and can recur.The customer cannot confirm if stat sample testing was affected.There are no known reports of patient intervention or adverse health consequences due to the reported event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2023-00043 on 15-feb-2023.Additional information (27-feb-2023): siemens reviewed the information provided and identified vacuum pump and reagent arm level sense failures and aspiration pressure errors when sampling from sample cups.The investigation confirms that the combination of errors could decrease throughput (turnaround time).A siemens customer service engineer (cse) was dispatched to the customer site to perform troubleshooting and service repair.Siemens completed a follow-up, reviewed the system data files, and found no errors.The reported issue was corrected, and there were no recurrences post-service repairs.The atellica direct load (dl) instrument operates as specified, and no further evaluation was required.Section h6 (type of investigation, investigation findings, and investigation conclusions) was updated to reflect the additional information.

• Brand Name: ATELLICA DIRECT LOAD
• Common Device Name: ATELLICA DIRECT LOAD
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; 62 flanders bartley rd.; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: rolando hualpa ; 511 benedict avenue; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 16378329
• Report Number: 2432235-2023-00043
• Device Sequence Number: 5759159
• Product Code: JJE
• UDI-Device Identifier: 00630414002347
• UDI-Public: 00630414002347
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K151767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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: ATELLICA DIRECT LOAD
• Device Catalogue Number: 11068008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (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