MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DCA VANTAGE ANALYZER

Catalog Number 10282970

Device Problem Insufficient Information (3190)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/05/2015

Event Type  Injury  

Event Description

Customer reported buffer solution splashed into operator's (nurse) left eye when she pulled a pull-tab.

Manufacturer Narrative

The dca vantage operators guide states, "using a smooth, slow, continuous motion, pull the flexible pull-tab completely out of the reagent cartridge." and "wear personal protective equipment, including safety glasses and gloves.Use universal precautions." the issue occurred while pulling the foil buffer tab before the sample was processed.This would indicate that the buffer has not yet come into contact with agglutinator, antibody latex, oxidant, or patient sample.As per siemens material safety data sheet (usa) for dca systems hemoglobin a1c reagent kit ((b)(4)), hba1c buffer solution has no known significant effects or critical hazards on eyes.As per eu safety data sheet, classification according to regulation (ec) no.(b)(4) [clp/ghs], hba1c buffer solution is not classified as hazardous according to regulation (ec).Siemens followed up on patient's health (eye), customer indicated that at this moment the symptoms persisting, ocular pressure, foreign body sensation, tearing and they also mentioned feel blurred vision and eye zone swollen the event has occurred due to an operator error.

• 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: 4838195
• MDR Text Key: 5914377
• Report Number: 1217157-2015-00074
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K071466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: 10282970
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability