MAUDE Adverse Event Report: CVS HEALTH EARLY RESULTS PREGNANCY TEST; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2021

Event Type  malfunction  

Event Description

Received two false positives after following directions on the cvs brand pregnancy test.Looked at reviews when i realized i was not pregnant and noticed hundreds of women also received false positives from this test.It is obviously detrimental to our mental health and our loved ones when we are trying to conceive.Women who are not trying to conceive also go through an emotional rollercoaster when they falsely test positive.This product should not be on the shelves with how many negative reviews there are regarding this issue.Fda safety report id # (b)(4).

• Brand Name: CVS HEALTH EARLY RESULTS PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• MDR Report Key: 12728656
• MDR Text Key: 279775511
• Report Number: MW5105058
• Device Sequence Number: 1
• Product Code: LCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/28/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 86