HARMONY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-18 for HARMONY manufactured by Ariosa.

Event Text Entries

[19346673] After having a previous pregnancy end with a trisomy 18 diagnosis, i opted to have the harmony non-invasive free cell blood test with a subsequent pregnancy. The test was performed at 10 weeks gestation. The test results came back 2 weeks later with a 99% positive result for monosomy x (turners syndrome). A nuchal translucency scan performed at 12 weeks showed no abnormalities or markers for chromosomal abnormalities. A cvs was subsequently performed at 12 weeks. Cvs results returned 2 weeks later with 46 normal chromosomes including two x sex chromosomes. I have come across an alarming number of women who have had non invasive free cell dna testing done and received positive results on the screenings, only to find out through invasive procedures (cvs, amnio, and cord-blood testing) that their babies are genetically healthy and "normal. " i believe these scans are not as accurate as advertised, and either they should not be testing sex chromosomes at all or should be publically sharing the alarming rates of false positive results for monosomy x.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5041599
• MDR Report Key: 4628123
• Date Received: 2015-03-18
• Date of Report: 2015-03-18
• Date of Event: 2015-01-21
• Date Added to Maude: 2015-03-25
• 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: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HARMONY
• Generic Name: PRENATAL TEST
• Product Code: MAO
• Date Received: 2015-03-18
• Model Number: NA
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: OTHER
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ARIOSA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-03-18