MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DCA VANTAGE

Catalog Number 10282969

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/03/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Customer indicated that she had tried asking the educator who informed her of the incident and the educator can't find the patient information to prove what they reported to siemens.They have tried looking at the document; they neither find the patient nor remember the patient's name.Siemens has requested additional information to customer in order to further investigate the issue.The cause for the issue is unknown.

Event Description

Customer reported discordant hemoglobin a1c result on the analyzer.

Manufacturer Narrative

Siemens customer care center received email from customer requesting this investigation be cancelled/close.They no longer want investigation as they believe it was an isolated incident that involved operator error after further investigation locally.The instrument has been placed back in service and is operational no more information will be coming regarding the patient or instrument.

• Brand Name: DCA VANTAGE
• 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: 5117514
• MDR Text Key: 27589813
• Report Number: 1217157-2015-00142
• 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: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10282969
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1