MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS (SHANGHAI) CO., LTD. CLEARBLUE 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 12/21/2022

Event Type  malfunction  

Event Description

Patient used clear blue pregnancy test at home and reports very clear positive result, in our clinic had 2 point of care negative results and a send out quantitative hcg(human chorionic gonadotropin) that was also negative.Had iud(intrauterine device) in place, late menses.

• Brand Name: CLEARBLUE PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS (SHANGHAI) CO., LTD.
• MDR Report Key: 16086072
• MDR Text Key: 306621789
• Report Number: MW5114117
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 12/28/2022

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
• 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: 12/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American