MAUDE Adverse Event Report: EXACT SCIENCE LABORATORIES/EXACT SCIENCES CORPORATION COLOGUARD TEST; SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION

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

Event Date 03/04/2024

Event Type  Injury  

Event Description

Utilized cologuard test.Returned positive abnormal.Colonoscopy was performed (b)(6) 2024, with nothing found, including no polyps.Per doctor 8 out of 10 are false positive.I am concerned about false negatives, this test is not a benefit but false assurances of no colon cancer present.Would like you to find out what stats they have regarding test results.I feel that this (b)(6) test is not accurate and should not be recommended.Informed my pcp doctor of findings and strongly recommend to not suggest.

• Brand Name: COLOGUARD TEST
• Type of Device: SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION
• Manufacturer (Section D): EXACT SCIENCE LABORATORIES/EXACT SCIENCES CORPORATION
• MDR Report Key: 18960188
• MDR Text Key: 338499949
• Report Number: MW5153055
• Device Sequence Number: 1
• Product Code: PHP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: AIRBORNE.; FISH OIL.; MAGNESIUM.; MULTIVITAMIN.; VITAMIN C.
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White