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

Model Number	ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As the customer was cleaning the centering collar on the laboratory's advia 2120i hematology system, her hand slipped and her finger was poked by the autosampler needle.The customer was wearing gloves at the time of the event.The customer washed the cut with soap and water and then went to the emergency room.The customer was given post exposure prophylaxis (pep) medication.The customer was also given an injection with a high plasma concentration to boost her immunity.The customer will have to have follow-up testing at 1, 3 and 6 months.There are no known reports of adverse health consequences due to this event.
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).The advia 2120/2120i hematology system operator's guide indicates "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 customer did not place the red needle cover over the needle.The cause of the event is use error.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• Common Device Name: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• 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: 15776005
• Report Number: 2432235-2022-00295
• Device Sequence Number: 4873588
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102644
• 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): 11/10/2022

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 WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10285573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2010
• 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