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 Device Handling Problem (3265)

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

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that an operator sustained a needlestick injury to the hand while performing maintenance on the advia 2120 hematology system with dual aspirate autosampler.Siemens determined that the cause of the needlestick injury to the operator's hand on the advia 2120 hematology system with dual aspirate autosampler was the operator's technique when performing the centering collar maintenance on the system.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 centering collar".The operator failed to follow the operator's guide instructions and did not cover the autosampler needle with the red needle cover.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer reported that an operator sustained a needlestick injury to the hand while performing maintenance on the centering collar on an advia 2120 hematology system with dual aspirate autosampler.The operator did not require medical intervention.The operator was tested for hepatitis b surface antigen, hepatitis c, hiv-1/hiv-2 antibody, hiv-1 p24 antigen, and the tests resulted (b)(6).The patient was also tested for hepatitis b surface antibody, and the test recovered (b)(6), which was expected.The operator was scheduled for subsequent testing of hepatitis b, hepatitis c dna/rna and hiv within 6 weeks, 3 months and 6 months.There are no known reports of adverse health consequences due to the operator sustaining a needlestick injury while performing maintenance on the centering collar on the advia 2120 hematology system with dual aspirate autosampler.

• 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.; chapel lane, swords, co.; registration number: 8020888; dublin, ; EI
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 7971681
• MDR Text Key: 126092818
• Report Number: 2432235-2018-00382
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• 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: 09/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2004
• 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