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

Model Number ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER

Device Problem Device Handling Problem (3265)

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

Event Date 05/29/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics inc.Has determined that the cause of the needlestick injury to the customer's finger on the advia 2120i with single aspirate autosampler instrument is the operator's technique when performing the centering collar maintenance on the instrument.The advia 120/ 2120/ 2120i hematology system operator's guide states the following: "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 entering collar." the operator failed to follow the operator's guide instructions and did not cover the auto sampler needle with the red needle stick cover immediately after removing the centering collar.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

The operator sustained a needlestick injury to the finger while performing the centering collar maintenance procedure on the advia 2120i with single aspirate autosampler instrument.The operator went to health service in the same hospital where she sustained her injury.The hospital followed the protocol of a biological risk and performed a blood test for hepatitis c virus (hcv), human immunodeficiency virus (hiv) and hepatitis b surface (hbs) for the operator.The operator received retroviral treatment.There are no known reports of adverse health consequences due to the customer sustaining a needlestick injury while performing the centering collar maintenance procedure on the advia 2120i with single aspirate autosampler instrument.

• 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 ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMIT; chapel lane, swords, co.; registration number: 8020888; dublin, ; EI
• Manufacturer Contact: elizabeth bernasconi ; 511 benedict ave; tarrytown, NY 10591 ; 9145242495
• MDR Report Key: 6630439
• MDR Text Key: 77430799
• Report Number: 2432235-2017-00357
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K102644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• 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
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2016
• 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
• Patient Age: 35 YR