MAUDE Adverse Event Report: LIPOSCIENCE INC VANTERA CLINICAL ANALYZER

Model Number 003-00095 ADH

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

A sequencing error in software code installed on a (b)(4) clinical analyzer resulted in a mismatch between sample id and test results reported.As a result of this software anomaly, incorrect test results were issued for a patient.The software anomaly did not cause an injury to the operator of the instrument.The incorrect test results were sent to a physician who contacted liposcience when the results were inconsistent with the patient's medical history and previous test results.There is no report of injury to the patient as a result of the physician receiving incorrect test results.

Manufacturer Narrative

The instrument was not returned to liposcience, however an evaluation was conducted by remote access function of the instrument.The evaluation that was conducted in provided is attached.

• Brand Name: VANTERA CLINICAL ANALYZER
• Type of Device: VANTERA
• Manufacturer (Section D): LIPOSCIENCE INC; raleigh NC
• Manufacturer Contact: suzette warner ; 2500 sumner blvd; raleigh, NC 27616-0000 ; 9192561326
• MDR Report Key: 4535826
• MDR Text Key: 5510857
• Report Number: 3007701857-2015-00001
• Device Sequence Number: 1
• Product Code: NSU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 003-00095 ADH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1