MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR XP

Device Problem Insufficient Information (3190)

Patient Problem Exposure to Body Fluids (1745)

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The customer required information about what was in the level 4 quality control material.The ccc specialist informed the customer that as per (b)(6) instructions for use, "the level 4 quality control material is biohazardous and the material should be treated as potentially infectious.The operator should handle this product according to the established good laboratory practices and universal precautions".The cause of the quality control material being splashed on the customer's face was related to the customer not wearing eye protection.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The operator of an advia centaur xp was splashed in the face with the enhanced (b)(6) level 4 quality control (qc) material while performing a calibration.The customer rinsed and washed her face.The customer was wearing a lab coat and the gloves but was not wearing eye protection.The customer is not sure if the material went into her eyes.The customer went to an emergency room where her eyes were checked and collected a blood sample to follow-up with the exposure protocol.There are no known reports of patient intervention or adverse health consequences due to quality control material being splashed on the customer's face.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, dublin ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 5069574
• MDR Text Key: 26650187
• Report Number: 2432235-2015-00397
• Device Sequence Number: 0
• Product Code: NHS
• Reporter Country Code: US
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2014
• 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