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

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2021

Event Type  malfunction  

Event Description

False positive on cologuard test.Fda safety report id # (b)(4).

• Brand Name: COLOGUARD
• Type of Device: SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION
• Manufacturer (Section D): EXACT SCIENCES CORPORATION
• MDR Report Key: 12260586
• MDR Text Key: 264951974
• Report Number: MW5102910
• Device Sequence Number: 1
• Product Code: PHP
• 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: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 68