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

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2022

Event Type  malfunction  

Event Description

Clear blue pregnancy test used at home - read at appropriate time mark, test came back positive.Patient evaluated in clinic with negative pregnancy test.Fda safety report id# (b)(4).

• Brand Name: CLEAR BLUE PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• Manufacturer (Section D): SPD SWISS PRECISION DIAGNOSTICS GMBH
• MDR Report Key: 13711069
• MDR Text Key: 287002528
• Report Number: MW5107961
• 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: 03/05/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2022
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female