MAUDE Adverse Event Report: SPD SWISS PRECISION DIAGNOSTICS GMBH CLEARBLUE PREGNANCY TEST; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Patient Problem Insufficient Information (4580)

Event Date 09/06/2023

Event Type  malfunction  

Event Description

Patient took a clearblue test and it showed positive.She then traveled out of state for abortion care where we determined that she is not, in fact, pregnant.

• Brand Name: CLEARBLUE PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• Manufacturer (Section D): SPD SWISS PRECISION DIAGNOSTICS GMBH
• MDR Report Key: 17728546
• MDR Text Key: 323284831
• Report Number: MW5145527
• Device Sequence Number: 1
• 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: 09/06/2023

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: 09/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White