MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DCA VANTAGE ANALYZER

Catalog Number 10282969

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

Customer reported discordant hemoglobin a1c (hba1c) results on the instrument.There was no report of injury due to this event.

Manufacturer Narrative

Customer confirmed that there was no harm to the patient due to this event.This event is in the process of being evaluated.The cause for the discordant hemoglobin a1c (hba1c) is unknown.

Manufacturer Narrative

Customer indicated that they had none of the lot in question remaining, and would not be returning cartridges for investigation.Customer also indicated that they had drawn five patients and run them both on the dca and through their core lab, and the biggest difference was only 0.2%.Customer indicated that they are satisfied with the instrument's performance and they do not require further support or follow-up.

• 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: 4438659
• MDR Text Key: 5317239
• Report Number: 1217157-2015-00008
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2014

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
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10282969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 01/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Patient Sequence Number: 1