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

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) sustained a needlestick injury while the cse performed service on a centering collar on an advia 2120i hematology system with dual aspirate autosampler.The centering collar on the advia 2120i hematology system with dual aspirate autosampler was out of place.The cause of the cse's needlestick injury is unknown.Siemens is investigating the issue.

Event Description

A siemens customer service engineer (cse) sustained a needlestick injury while the cse performed service on a centering collar on an advia 2120i hematology system with dual aspirate autosampler.The wound was cleaned.There are no known reports of medical intervention or adverse health consequences due to the event.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2019-00270 on 08-aug-2019.Additional information (13-aug-2019): it was reported that the siemens customer service engineer (cse) did not use the needle guard while performing centering collar maintenance.Advia 2120/advia 2120i operators guide, smn 10708774 rev.03, 2019-03 states under section 4, maintaining the analyzer, "warning, 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.Be careful not to bend the needle as you slip the cover over it." therefore, the cse's injury was due to a use error.Result code and conclusion code in section h6 were updated based on the additional information.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• MDR Report Key: 8875973
• MDR Text Key: 208642452
• Report Number: 2432235-2019-00270
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (y/n): N
• PMA/PMN Number: K102644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

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
• Device Operator: Health Professional
• Device Model Number: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10285573
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR