MAUDE Adverse Event Report: UNKNOWN MYRIAD NIPT TEST; LABORATORY DEVELOPED TEST

Device Problem False Positive Result (1227)

Patient Problem Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 11/25/2020

Event Type  Injury  

Event Description

I was offered the myriad nipt when i was pregnant with my twin boys.I agreed to it.The results showed that my twins both had a 70% chance of having trisomy 13, which is fatal.I continued the pregnancy and delivered two healthy boys in may 2021.The test was a false positive.However, the emotional burden was heavy during my pregnancy.

Event Description

Additional information received on 02/13/2023 for mw5114346 to change procode.

• Brand Name: MYRIAD NIPT TEST
• Type of Device: LABORATORY DEVELOPED TEST
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16185956
• MDR Text Key: 307669712
• Report Number: MW5114346
• Device Sequence Number: 1
• Product Code: OQS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Race: White