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

Catalog Number	10282969
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer stated that discrepant low microalbumin and creatinine results were obtained when compared to another dca system.The issue occurred with two different samples.There is no report of harm due to this event.
Additional Manufacturer Narrative
Siemens has requested more information for further investigation.The cause of this event is unknown.
Additional Manufacturer Narrative
Siemens tested ten cartridges of returned product from lot 0011082 with a control range of: alb 27.90 / cre 398.30 mg/g.All results were recorded and compared to expected results.All microalbumin and creatinine results were within expected ranges.Batch records and shift notes were also reviewed for any issues relating to this complaint.Batch records and shift notes did not indicate any issues related to this complaint and the certificate of analysis indicates that the lot in use at the time of the event performed to specification at the time of manufacturing release.No product problem identified.

• 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: thomas myers ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 17391243
• Report Number: 3002637618-2023-00052
• Device Sequence Number: 8942603
• Product Code: LCP
• UDI-Device Identifier: 00630414551364
• UDI-Public: 00630414551364
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/28/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown