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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2022

Event Description

Clear blue pregnancy test was positive and then two home pregnancy tests after were negative, and our test was negative in office.False positive test - clear blue.

• 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: 15104850
• MDR Text Key: 296706462
• Report Number: MW5111118
• 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: 07/22/2022

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?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2022
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female