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

Model Number ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER

Device Problems Leak/Splash (1354); Sticking (1597); Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/05/2015

Event Type  malfunction  

Event Description

The customer stopped the operation of the advia 2120i with single aspirate autosampler instrument to investigate a leak.The instrument was in standby mode but the aspirate mechanism appeared stuck.The customer attempted to get a hold of the mechanism to unstick it and her finger was pierced by the aspirate needle.It is unknown if the customer was wearing personal protective equipment nor if the customer covered the aspirate needle with the red needle cover prior to trying to fix the aspirate mechanism.There are no known reports of adverse health consequences due to the customer's finger being pierced by the aspirate needle.

Manufacturer Narrative

The customer contacted siemens healthcare diagnostics inc.(siemens).Siemens determined that the cause of the event is due to the user interfacing with the advia 2120i with single aspirate autosampler instrument.The customer visited the occupational health department at leighton hospital, where blood was drawn, the finger wound was made to bleed out and a plaster was applied.The customer was given a hepatitis b booster vaccination and her blood will be monitored for six weeks for evidence of infection.The instrument is performing according to specifications.No further evaluation of this device is required.

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) filed the initial mdr 2432235-2015-00101 on march 16, 2015.Additional information (march 18, 2015): when the customer was trying to dislodge the aspirate mechanism, the system was stopped and in standby mode.The advia 2120/2120i operator guide advises to use the aspirate needle cover when performing maintenance around the centering collar of the aspirate needle.The customer did not use the needle cover to protect herself as the centering collar was in place and she was not aware that the aspirate needle was protruding until it pierced her finger when she reached in and grabbed the aspirate mechanism to dislodge it.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; registration number: 8020888; chapel lane; swords, co. dublin ; EI
• Manufacturer Contact: elizabeth bernasconi ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242495
• MDR Report Key: 4605714
• MDR Text Key: 5696265
• Report Number: 2432235-2015-00101
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

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 WITH SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10488923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 03/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2011
• 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