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 05/21/2014

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 indicated that they performed maintenance, passed the optical test, and successfully performed a precision and correlation study using patient samples.Results of the study were not provided.Customer indicated that they started having issues with repeated error (107) and issues inserting the cassettes into the instrument.Siemens technical solutions team has exchanged the customer's instrument.No further investigation can occur as customer no longer is using this instrument.Before the instrument malfunctioned, the customer indicated that they successfully tested their reagent and determined that it was performing as expected.

• 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: 3961923
• MDR Text Key: 4606457
• Report Number: 1217157-2014-00108
• 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
• Reporter Occupation: Phlebotomist
• Type of Report: Initial
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1