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

Model Number ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2022

Event Type  malfunction  

Event Description

A siemens customer service engineer (cse) was poked on the pinky finger by the autosampler needle while replacing the coupler plate and restrictor on a customer's advia 2120 hematology system.The cse was wearing gloves at the time of the event.After being poked by the needle, the engineer removed their glove and washed their hand and the poked area with soap and water.The engineer went to the emergency room, had blood drawn, and was prescribed a preventative hiv pill combo.There are no known reports adverse health consequences due to this event.

Manufacturer Narrative

The customer service engineer (cse) had to remove the centering collar when replacing the coupler plate and restrictor.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 cse did not place the red needle cover over the needle.Siemens is investigating the issue.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2022-00291 on 28-oct-2022.Additional information (08-nov-2022): while performing preventive maintenance on the customer's advia 2120 hematology system, the customer service engineer (cse) did not place the red needle cover over the needle, as per service instructions.Using the red needle cover protects the engineer from inadvertently poking the skin.The cse was fully trained but missed the step while doing the preventive maintenance.This is an isolated event.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 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120 HEMATOLOGY SYSTEM 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: 15692445
• MDR Text Key: 307167779
• Report Number: 2432235-2022-00291
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10313419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1