VERIFI NIPT TEST *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-20 for VERIFI NIPT TEST * manufactured by *.

Event Text Entries

[5612392] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5041668
• MDR Report Key: 4643292
• Date Received: 2015-03-20
• Date of Report: 2015-03-20
• Date of Event: 2014-04-18
• Date Added to Maude: 2015-04-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VERIFI NIPT TEST
• Generic Name: NIPT TEST
• Product Code: MAO
• Date Received: 2015-03-20
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: *
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-03-20