MAUDE Adverse Event Report: TARGET GENERAL MERCHANDISE, INC. UP & UP ADVANCED EARLY RESULT PREGNANCY TEST; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 10/24/2021

Event Type  malfunction  

Event Description

Received two false positives after following directions for pregnancy test.Looked at reviews when i realized i was not pregnant and noticed hundreds of other women had the same issue.It is obviously detrimental to us and our loved ones when we are trying to conceive.It is also an emotional rollercoaster for those not trying to conceive 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: UP & UP ADVANCED EARLY RESULT PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• Manufacturer (Section D): TARGET GENERAL MERCHANDISE, INC.; 33 south sixth street; mailstop cc- 3403 ; minneapolis MN 55402
• MDR Report Key: 12728438
• MDR Text Key: 279822668
• Report Number: MW5105044
• 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