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

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center and reported that an operator was injured while troubleshooting an error on the advia 2120i hematology system with single aspirate autosampler.A siemens customer service engineer (cse) was dispatched to the customer's site and performed maintenance on the system.The cause of the operator's needlestick injury was related to the operator not following the instructions advised in the advia 120/ 2120/ 2120i hematology system operator's guide.The operator's guide advises operators of these systems to "call siemens service for assistance" when this error is triggered."only siemens service personnels are authorized to take this corrective action." the system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
An operator of an advia 2120i hematology system with single aspirate autosampler sustained a needlestick injury to the finger while troubleshooting an "autosampler-pushpin jammed" error on the system.The operator was injured by the autosampler needle when the operator removed the centering collar.The operator disinfected the affected area, received first aid treatment, and will be tested for infectious diseases [(b)(6)].There are no known reports of adverse health consequences due to the customer sustaining a needlestick injury while troubleshooting error "autosampler-pushpin jammed" on the advia 2120i hematology system with single aspirate autosampler.
Additional Manufacturer Narrative
Siemens filed the initial mdr on 30-jan-2019.Additional information (04-feb-2019): the initial mdr indicated that when a siemens customer service engineer (cse) was dispatched to the customer's site, the cse performed maintenance on the system.Siemens is clarifying that the maintenance performed on the system included alignment, calibration and replacement of the single aspirate autosampler (saa).The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 8288469
• Report Number: 2432235-2019-00044
• Device Sequence Number: 2418741
• Product Code: GKZ
• UDI-Device Identifier: 00630414581965
• UDI-Public: 00630414581965
• 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,Followup
• Report Date (Section B): 02/11/2019

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 SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10488923
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1