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

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2022

Event Type  malfunction  

Event Description

We have had multiple patients come to our health center thinking that they were pregnant when in fact they weren't.99% of these patients reported using a clearblue test that they purchased at the pharmacy.I'm concerned about the high false positive rate with the clearblue test and believe it should be taken off the market.Fda safety report id# (b)(4).

• Brand Name: CLEARBLUE PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• MDR Report Key: 13848108
• MDR Text Key: 287798444
• Report Number: MW5108402
• Device Sequence Number: 1
• Product Code: LCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2022

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female