MAUDE Adverse Event Report: AT HOME PREGNANCY TEST; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2022

Event Type  malfunction  

Event Description

I am reporting that a patient had three positive at home pregnancy tests, and she is actually not pregnant based on in-clinic urine and blood tests.This has been happening with so many patients.Most patients it is the clear blue test but there have been some others.I know many other doctors have reported this.You need to look into this - it is a systemic problem that started a couple months ago.I am really surprised i haven't heard anything about a recall yet.Fda safety report id # (b)(4).

• Brand Name: AT HOME PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• MDR Report Key: 13929548
• MDR Text Key: 288172518
• Report Number: MW5108550
• Device Sequence Number: 2
• Product Code: LCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native