MAUDE Adverse Event Report: UNKNOWN NON-INVASIVE PRENATAL PATERNITY TEST; LABORATORY DEVELOPED TEST

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Falsified prenatal noninvasive paternity test."(b)(6) lab" claims to be accredited by aabb and advertise to be "99.999% accurate".Tested at 11 weeks pregnant with (b)(6) lab was told "(b)(6)" was 99.999% father.Retested with ddc at 34 weeks pregnant was told "(b)(6)" was 0% father.Gave birth (b)(6) 2024 did a post paternity test with (b)(6) lab and was told "(b)(6)" was 99.999% father.Tested with (b)(6) lab as well with "(b)(6)" was 99.999% father.When this was mentioned to (b)(6) lab for false results of prenatal testing, they claimed "were accredited our results won't ever change." i have sent emails to amazon of the matter as well as tried posting reviews of the company.However, they filter out reviews and delete negative reviews.They are a scam and take your money, and never truly do a dna test only 50/50 chance results.I have come across a dozen people in the last 6 months who have been affected by falsified results.

• Brand Name: NON-INVASIVE PRENATAL PATERNITY TEST
• Common Device Name: LABORATORY DEVELOPED TEST
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 20312359
• Report Number: MW5160146
• Device Sequence Number: 7826029
• Product Code: OQS
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White