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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer contacted a siemens customer care center (ccc) and informed them that a drop of blood from the aspiration tube splashed into the operator's eye while they were removing a sample in open mode on an advia 2120i hematology system with dual aspirate autosampler.A siemens customer service engineer (cse) was dispatched to the customer site.The cse analyzed the instrument and did not find an instrument malfunction.The cause of the event was due to the operator removing the sample from the advia 2120i hematology system with dual aspirate autosampler too quickly and not wearing facial protection as required in the operator's guide.The instrument is performing according to specifications.No further evaluation of the device is required.
Event or Problem Description
A customer reported that a drop of blood from the aspiration tube splashed into the operator's eye while they were removing a sample in open mode on an advia 2120i hematology system with dual aspirate autosampler (sn: (b)(4)).The operator went to their occupational health department, flushed the eye and had blood drawn for baseline blood tests.The operator was tested for infectious diseases ((b)(6)) and the results reported were (b)(6) for both.There no known reports of adverse health consequences due to the drop of blood splashed in the operator's eye.

• 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
• MDR Report Key: 8504369
• Report Number: 2432235-2019-00115
• Device Sequence Number: 1474306
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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: 10285573
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1