MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DCA VANTAGE

Catalog Number 10282970

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

The operator washed their eyes with water and was seen by a doctor and no injuries were found.Per the hba1c sds, "this material is not considered hazardous".The operator was not wearing personal protective equipment.As per the operator's guide: "wear personal protective equipment, including safety glasses and gloves.Use universal precautions." in addition, proper technique was not followed.The customer stated that after the operator inserted the reagent cartridge into the device, he pulled out the flexible tab vigorously.The hba1c quick reference guide instructs the operator to "slowly and smoothly pull to remove the flexible tab".

Event Description

The customer reported that after inserting the reagent cartridge into the dca vantage instrument, the operator removed the pull tab with a quick, abrupt movement, causing buffer solution to splash out of the cartridge and into their eyes.The operator was not wearing ppe and was seen by a doctor and no injuries were found.

• Brand Name: DCA VANTAGE
• Type of Device: DCA VANTAGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 11784915
• MDR Text Key: 252234846
• Report Number: 3002637618-2021-00031
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10282970
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: No
• 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