MAUDE Adverse Event Report: CLEARBLUE DIGITAL PREGNANCY TEST; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Device Problem False Positive Result (1227)

Patient Problem Distress (2329)

Event Date 05/02/2022

Event Type  malfunction  

Event Description

A (b)(6) female took a clearblue brand digital pregnancy test that resulted positive.The patient felt stressed out for 2 weeks anticipating needing an abortion.When she came to the clinic, her in-clinic pregnancy test was negative x 2.No bleeding/period had occurred.The patient experienced significant emotional distress due to the false positive clearblue brand digital pregnancy test.This is not an isolated incident.There have been at least 10 other similar incidents at my clinic in the last 6 months with false positive clearblue and clearblue digital pregnancy tests.Fda safety report id# (b)(4).

• Brand Name: CLEARBLUE DIGITAL PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• MDR Report Key: 14337354
• MDR Text Key: 291326782
• Report Number: MW5109596
• Device Sequence Number: 5
• 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: 05/04/2022
• 11 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11

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: 05/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female