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

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/11/2019

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 136931607
• Report Number: 2432235-2019-00044
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414581965
• UDI-Public: 00630414581965
• Combination Product (y/n): N
• PMA/PMN Number: K162977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 02/04/2019
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1