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

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported an operator sustained a needlestick injury while troubleshooting the advia 2120i hematology system with dual aspirate.The customer specified that the operator sustained the injury when they removed the centering collar.The customer also indicated that the autosampler initiated during this time.A siemens customer service engineer (cse) on site at the time tested the system interlocking.The advia 2120/2120i hematology system operator¿s guide indicates to "place the red needle cover over the needle." after removing the centering collar.Additionally, the operator's guide indicates "the analyzer must be off; otherwise personal injury from the needle can occur." the operator did not turn off the analyzer and did not to place the red needle cover over the needle when troubleshooting the leak.Therefore, the cause of the event is use error.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
While troubleshooting a leak on the customer¿s advia 2120i hematology system with dual aspirate, an operator sustained a needlestick injury when they removed the centering collar.The customer was wearing gloves and a lab coat at the time of the event.The customer went to the accident and emergency department, where they were given a course of anti-virals.The operator was also given hepatitis b vaccination on the following day.There are no known reports of adverse health consequences due to this event.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; registration number: 8020888; chapel lane, swords, co.; dublin ; EI
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 17398476
• Report Number: 2432235-2023-00224
• Device Sequence Number: 5921947
• Product Code: GKZ
• UDI-Device Identifier: 00630414019772
• UDI-Public: 00630414019772
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2023

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
• Device Catalogue Number: 11219529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown