MAUDE Adverse Event Report: ARIOSA DIAGNOSTICS INC./ROCHE DIAGNOSTICS OPERATIONS INC. HARMONY NIPT; DNA-PROBE, HUMAN CHROMOSOME

Device Problem False Positive Result (1227)

Patient Problems Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2018

Event Type  Death  

Event Description

On (b)(6) 2018, i had my blood drawn for the harmony nipt(non-invasive prenatal testing) test because i was going to be 35 at the time of delivery (advanced maternal age).On (b)(6) 2018, a genetic counselor informed me that the test had come back with a 99.9% likelihood of our baby girl having trisomy 13.He explained that there was a chance this result could be a false positive and referred us for an invasive test (cvs) the following day.The mfm (maternal-fetal medicine) doctor we saw the next day recommended we skip the cvs(chorionic villus sampling) due to the higher chance of miscarriage and wait three weeks until i was far enough along to have an amniocentesis (statistically, a safer procedure).We followed the doctor's recommendation and waited until i was nearly 16 weeks along to have the amnio.The amnio showed the test had returned a false positive; our daughter did not have trisomy 13.Unfortunately, the amnio also caused a partial placental abruption with heavy bleeding, leading me to three different hospital visits/stays over the next six weeks.The bleeding from the placental abruption then caused my water to break at 18 weeks 3 days pregnant.Without any amniotic fluid, our daughter's lungs would not develop and i was at high risk of infection, so we had to make the heartbreaking decision to end our very wanted pregnancy at 19 weeks pregnant to spare our daughter any suffering.We induced labor and delivered our baby girl ivy on (b)(6) 2018.She had no heartbeat.None of this trauma would have happened had we not had a false positive result from the harmony test that led to the recommendation for invasive testing.Unfortunately, the harm did not stop there.Approximately nine months after the death of our baby ivy, we were fortunate enough to get pregnant again.We were assured that the false positive harmony test in our first pregnancy was a fluke, and since no other nipt tests were covered by our insurance, we proceeded to have the test again.*for the second time*, the harmony test came back positive for trisomy 13.We were devastated and were reliving our trauma all over again.Given our previous experience, we declined invasive testing this time and chose instead to monitor our baby via ultrasound and were also offered a different nipt, the panorama, to see if we got the same results.The panorama test came back negative for trisomy 13.Our baby boy was thankfully born completely healthy on (b)(6) 2020.A second false positive result from harmony.Our genetic counselors and doctors were baffled.No one knew of a case of back-to-back false positive results.Clearly, there was a flaw with harmony's test.Our genetic counselors contacted the company that offers the harmony test to inform them of the back-to-back false positive trisomy 13 results, alert them that there was an issue with their test, and ask for answers.The response they got back said that the company "was not interested in pursuing the matter." the harmony test robbed me of a daughter.It also robbed me of a happy, joyful pregnancy with my son when it returned a positive trisomy 13 result for a second time.I have no recourse in the matter, despite the life-altering effect this test has had on my life and the lives of my husband and family.Please - help me get some recourse.An explanation.Anything.Or at the very least, please take fda action against harmony for the trauma it has put me and will put other families through.It is only a matter of time before their flawed test leads to another baby's death.Thank you.Fda safety report id# (b)(4).

• Brand Name: HARMONY NIPT
• Type of Device: DNA-PROBE, HUMAN CHROMOSOME
• Manufacturer (Section D): ARIOSA DIAGNOSTICS INC./ROCHE DIAGNOSTICS OPERATIONS INC.; 9115 hague rd; indianapolis IN 46250
• MDR Report Key: 15833552
• MDR Text Key: 304004425
• Report Number: MW5113373
• Device Sequence Number: 2
• Product Code: MAO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/16/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Death; Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White