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

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported smoke emitted from an advia 2120i hematology system with dual aspirate autosampler due to a malfunctioned black wire from the autosampler.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse repaired the malfunctioned wire, which allowed the instrument to return to normal operation.The instrument is performing according to specifications.No further evaluation of the device is required.
Event or Problem Description
The customer reported smoke emitted from an advia 2120i hematology system with dual aspirate autosampler due to a malfunctioned black wire from the autosampler.The customer confirmed that there were no visible flames associated with the smoke.The customer had a backup instrument to process samples when the instrument was down.There are no known reports of adverse health consequences due to this event.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 17586023
• Report Number: 2432235-2023-00237
• Device Sequence Number: 4917287
• Product Code: GKZ
• UDI-Device Identifier: 00630414019772
• UDI-Public: 00630414019772
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2023

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 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• 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: 07/28/2023
• Initial Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2020
• 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 Sex: Unknown