MAUDE Adverse Event Report: VERIFI NIPT TEST

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 04/18/2014

Event Type  No Answer Provided  

Event Description

Received positive result for turners syndrome with verifi test in (b)(6) 2014.Had to undergo invasive and risky amniocentesis to check results only to find out it was a false positive.Verifi claims to be 99% accurate but it clearly isn't.Manufacturer reported as verifi.

• Brand Name: VERIFI NIPT TEST
• Type of Device: NIPT TEST
• MDR Report Key: 4643292
• MDR Text Key: 5612392
• Report Number: MW5041668
• Device Sequence Number: 1
• Product Code: MAO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRENATAL VITAMINS
• Patient Age: 30 YR
• Patient Weight: 70