MAUDE Adverse Event Report: SEQUENOM MATERNIT21

Device Problem False Negative Result (1225)

Patient Problem Miscarriage (1962)

Event Date 09/03/2015

Event Type  Death  

Event Description

When i was 12 weeks pregnant, my prof., doctor said that there was down syndrome risk with my baby and he recommended me to have been done maternit21 test.The test result was negative and we were so happy.The lab said that they were also happy to give us that good news.My doctor said that also he had some evidence of down syndrome, because the result is negative, so the baby is healthy.When i was around 21 weeks pregnant, i went to another prof for detailed ultrasound.He said that, he had also findings for down syndrome and recommended to have an amnio test.Unfortunately, the result was positive and baby had the down syndrome.I had to get an abortion at the week 24.Placenta was analyzed at the university and there was down syndrome cells against (b)(4)'s declaration that it was mosaic type down syndrome and placenta was clean and that was the reason why the test could not catch down syndrome cells.It was horrible days for me and still i am feeling so bad especially to have sin for abortion when the baby is so big.(b)(4) is guilty for producing tests which gives false negative result.Their result of correctness do not reflect the real percentages.If a test is giving false negative and false positive results, how can we believe the correctness of this test.Rather than having this test, amnio is the only option of exact result.I hope the god punishes sequence badly for making us to live these bad days.I am planning to go to court so that they can be punished for what they have caused in our lives.If they are earning very high commercial income out of these tests, they have to be ready taking the risk of misleading us with the wrong info and horrifying our lives.

• Brand Name: MATERNIT21
• Type of Device: MATERNIT21
• Manufacturer (Section D): SEQUENOM
• MDR Report Key: 5096387
• MDR Text Key: 26630931
• Report Number: MW5056359
• Device Sequence Number: 1
• Product Code: OQS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 09/17/2015

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
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Death
• Patient Age: 36 YR
• Patient Weight: 66