MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I WITH DUAL ASPIRATE

Model Number	ADVIA 2120I WITH DUAL ASPIRATE
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there was a wrong association between sample id and patient id for two patients on an advia 2120i hematology system: 1) sample id: (b)(6); patient id: (b)(6).2) sample id: (b)(6); patient id: (b)(6).In both cases the advia 2120i hematology system read patient id (b)(6) (without the last numbers 4 and 1).For this reason, on the advia 2120i software, there was the same patient name for both the sample ids.The incorrect results were not reported out to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).The atellica data manager log files are being reviewed.Siemens is investigating the issue.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2024-00063 on 08-apr-2024.Additional information (02-may-2024): the advia 2120i hematology system reads patient ids up to 14 digits, but in this case the patient ids were found to be 15 digits in length (b)(6).Since the system can only read 14 characters, the last character was omitted.The investigation findings and investigation conclusions codes in section in h6 were updated based on the additional information.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120I WITH DUAL ASPIRATE
• Common Device Name: ADVIA 2120I WITH DUAL ASPIRATE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; registration number: 8020888; chapel lane, swords, co; dublin ; EI
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 19062053
• Report Number: 2432235-2024-00063
• Device Sequence Number: 12431612
• Product Code: GKZ
• UDI-Device Identifier: 00630414019772
• UDI-Public: 630414019772
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162977
• 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,Followup
• Report Date (Section B): 05/10/2024

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: ADVIA 2120I WITH DUAL ASPIRATE
• Device Catalogue Number: 11219529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• 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: A
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male