MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS (SHANGHAI) CO., LTD. CLEAR BLUE PREGNANCY TEST - STANDARD; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2022

Event Type  malfunction  

Event Description

Describe event, problem, or product use error: patient with two false positive clear blue pregnancy tests at home, resulting in unnecessary travel to seek care several hundred miles out of state.

• Brand Name: CLEAR BLUE PREGNANCY TEST - STANDARD
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS (SHANGHAI) CO., LTD.
• MDR Report Key: 15699225
• MDR Text Key: 302808622
• Report Number: MW5112962
• 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: 10/27/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female