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

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2022

Event Type  malfunction  

Event Description

False positive test twice.Urine pregnancy test.Fda safety report id # (b)(4).

• Brand Name: CLEARBLUE
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• MDR Report Key: 13757556
• MDR Text Key: 287247726
• Report Number: MW5108116
• 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: 03/09/2022
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2022
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic