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U.S. Department of Health and Human Services

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

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UNKNOWN MYRIAD NIPT TEST; LABORATORY DEVELOPED TEST Back to Search Results
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.
 
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Brand Name
MYRIAD NIPT TEST
Type of Device
LABORATORY DEVELOPED TEST
Manufacturer (Section D)
UNKNOWN
MDR Report Key16185956
MDR Text Key307669712
Report NumberMW5114346
Device Sequence Number1
Product Code OQS
Combination Product (y/n)N
Number of Events Reported1
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 Received01/13/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/15/2023
Patient Sequence Number1
Patient Outcome(s) Other; Life Threatening;
Patient Age36 YR
Patient SexFemale
Patient RaceWhite
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