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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center.During routine work, the operator passed the system and sustained an injury from a metal edge of the input queue of an advia 2120i hematology system with single aspirate autosampler.Siemens further investigated the event and determined that during normal operations, the input queue metal edges are only exposed during the movement of the racks.These edges are smoothed when the system is manufactured.The cause of the injury was not associated with a sample loading issue or a system malfunction.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 tripped on the floor and fell near the input queue of an advia 2120i hematology system with single aspirate autosampler.The operator sustained an injury to the arm from the metal edge of the system; the operator applied an adhesive tape to the cut and was tested for infectious diseases.No further medical intervention was required.There are no known reports of adverse health consequences due to the operator's injury to the arm.

• 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: 7770173
• Report Number: 2432235-2018-00317
• Device Sequence Number: 16599126
• Product Code: GKZ
• UDI-Device Identifier: 00630414581965
• UDI-Public: 00630414581965
• 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): 08/09/2018

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 SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10488923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1