MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DCA VANTAGE

Catalog Number	10282969
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that the operator's eyes were exposed to hba1c reagent mixed with patient blood.Exposure occurred while the operator was running a hba1c sample.The operator pulled the buffer tab on the hba1c reagent and the reagent mixed with blood sample sprayed their eyes.The operator was not wearing eye protection when the indent occurred.Following the exposure the operator used the eye wash station but did not seek medical attention.Customer stated the operator is doing well.
Additional Manufacturer Narrative
A reviewed of the certificate of analysis for the reagent lot in use at the time of the event was performed and has passed all specifications upon manufacturing release.A review of the complaint database has shown that there are no other reports of leaking product for this reagent lot.It is recommended that operators wear proper protective equipment to avoid exposure.The cause of this event is unknown.

• Brand Name: DCA VANTAGE
• Common Device Name: DCA VANTAGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 19184687
• Report Number: 3002637618-2024-00047
• Device Sequence Number: 7148028
• Product Code: LCP
• UDI-Device Identifier: 00630414551364
• UDI-Public: 00630414551364
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K071466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10282969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown