MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DCA VANTAGE

Catalog Number 10282969

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Customer has been advised that it is standard practice to wipe the finger with alcohol and make sure the finger is dry before taking a sample as oils from the skin and/or left over alcohol could dilute the sample.Moreover, when working with a venipuncture sample it is important to make sure that the sample is well mixed.Issues can also arise when excess sample remains on the outside of the capillary tube as this can lead to higher than expected values.Siemens does recommend wiping any excess however it is important to keep the wipe from touching the bottom of the capillary which could lead to loss of sample (and thus lower than expected results).Customer indicated that they are happy with data and quality control results at this moment.The cause for the discordant hemoglobin a1c results is unknown.

Manufacturer Narrative

Siemens customer service engineer went on site and checked the instrument.Cse indicated that they could not reproduce discrepant results using proper technique.This complaint is not confirmed.It was found that the customer was not following proper technique for all samples.The customer indicated that they are fully satisfied with the instrument and are confident that instrument is producing appropriate results.Customer also indicated that they will re-train their operators.

• 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: 4148562
• MDR Text Key: 4911367
• Report Number: 1217157-2014-00148
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10282969
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 21 YR