MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DCA VANTAGE ANALYZER

Catalog Number 10282969

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)

Patient Problem Contamination, chemical (2455)

Event Date 06/02/2014

Event Type  malfunction  

Event Description

Customer reported that cartridge fluid was splashed into operator's eye while preparing a sample.

Manufacturer Narrative

As per dca operator's manual, "to prevent accidental contamination in a clinical laboratory, strictly adhere to the following procedures: · wear personal protective equipment such as safety glasses, gloves, lab coats or aprons when working with possible biohazard contaminants.· keep your hands away from your face." customer indicated that operator was wearing only gloves and not safety glasses.The event has occurred due to an operator error.

Manufacturer Narrative

The operator is not having any adverse affects.Operator is feeling fine and having no sight issues.Operator was not wearing eye protection at the time of the incident.

Manufacturer Narrative

Siemens representative spoke to the instrument operator that had the incident.Operator indicated that she had immediately gone to occupational health.They gave her an additional eye wash as well as a (b)(6) panel which came back (b)(6).Operator indicated that she did experience some eye irritation for a couple of days after the incident but that it is no longer bothering her but just to be safe she has an appointment with her eye doctor in a couple of weeks.

Manufacturer Narrative

Customer indicated that the operator followed up with her doctor and there are no continuing problems and her eyes appear to be fine.

• Brand Name: DCA VANTAGE ANALYZER
• Type of Device: DCA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3907206
• MDR Text Key: 4495084
• Report Number: 1217157-2014-00091
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10282969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1