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

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer contacted a siemens customer care center (ccc).Siemens reviewed the files that were provided by the customer.The back-flush procedure is a task performed by the operator as part of the advia 2120i hematology instrument maintenance.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 cse realigned the red blood count (rbc) flow cell and adjusted the gains with the opti point.The cause of the event was due to the operator not wearing a facial protection as required in the operator guide.The instrument is performing according to specifications.No further evaluation of the device is required.
Event or Problem Description
Customer reported, while performing the back-flush cleaning procedure on the advia 2120i hematology system with single aspirate, distilled water sprinkled on the operator's face.On the date of the event, the operator wore personal protective equipment (ppe) but did not wear safety glasses or a safety mask.The operator rinsed their face with tap water.The operator did not receive infectious diseases treatment nor medical attention/treatment due the exposure to the distilled water.There no known reports of adverse health consequences due to the distilled water sprinkled on the operator's face.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8371415
• Report Number: 2432235-2019-00073
• Device Sequence Number: 1333023
• Product Code: GKZ
• UDI-Device Identifier: 00630414019789
• UDI-Public: 00630414019789
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2019

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 SINGLE ASPIRATE
• Device Catalogue Number: 11219530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1