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

Model Number	ADVIA 2120I WITH SINGLE ASPIRATE
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An erroneous, falsely elevated platelet (plt) result was obtained on a patient sample on an advia 2120i hematology system.The erroneous result was reported to the physician(s) and was questioned, as a lower result was expected since the patient had malaria.The sample was run on a non-siemens system and the plt result also recovered falsely elevated.The sample was repeated for plt on an alternate advia 2120i hematology system as well as on the non-siemens system, recovering lower.The lower plt result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated platelet result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).The red blood cell flowcell (rbc flc) was changed, the rbc sheath filter was replaced, and all reagents were primed.The system is fully operational after the service intervention.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120I WITH SINGLE ASPIRATE
• Common Device Name: ADVIA 2120I WITH SINGLE 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: 18409638
• Report Number: 2432235-2023-00343
• Device Sequence Number: 8766923
• Product Code: GKZ
• UDI-Device Identifier: 00630414019789
• UDI-Public: 00630414019789
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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
• Report Date (Section B): 12/28/2023

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: ADVIA 2120I WITH SINGLE ASPIRATE
• Device Catalogue Number: 11219530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2019
• 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
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Male