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	Device Handling Problem (3265)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Siemens determined that the cause of the needlestick injury to the operator's hand on the advia 2120i hematology system with dual aspirate autosampler was the operator's technique when performing the centering collar maintenance on the system.The advia 120/ 2120/ 2120i hematology system operator's guide states the following: "to avoid personal injury and exposure to a potential biohazard, you must cover the needle with the red needle cover immediately after you remove the centering collar." the operator failed to follow the operator's guide instructions and did not cover the autosampler needle with the red needle cover.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that an operator sustained a needlestick injury to the hand when performing maintenance on an advia 2120i hematology system with dual aspirate autosampler.The operator stubbed and scratched her hand with the autosampler needle while removing the centering collar.The customer reported that the operator received necessary medical care, but did not provide further details regarding the medical treatment administered to the operator.The customer alleged that since a(b)(6)sample was run on the system, the operator underwent (b)(6) related tests.There are no known reports of adverse health consequences due to the operator sustaining a needlestick injury while performing maintenance on the advia 2120i hematology system with dual aspirate autosampler.

• 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: 8113151
• Report Number: 2432235-2018-00440
• Device Sequence Number: 1913568
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/28/2018

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: 11/07/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1