MAUDE Adverse Event Report: EXACT SCIENCES CORP. COLOGUARD TEST KIT; SYSTEM, COLORECTAL NEOPLASIA

Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Codes	Distress (2329); No Code Available (3191)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Cologuard test stating 92% correct.I was sent a "positive" result by them.It proved to be negative after a colonoscopy and sedation.I would like it documented to add my result to the false positive reports.I believe there is a possibility of over stating their correctness.The doctor and nursing staff had said they had been seeing quite a bit of this false positive from cologuard.This is emotionally, financially and physically stressful.

• Brand Name: COLOGUARD TEST KIT
• Common Device Name: SYSTEM, COLORECTAL NEOPLASIA
• Manufacturer (Section D): EXACT SCIENCES CORP.
• MDR Report Key: 7960454
• Report Number: MW5080522
• Device Sequence Number: 1770983
• Product Code: PHP
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2018
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 67