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

Device Problems False Negative Result (1225); Product Quality Problem (1506)

Patient Problem Cancer (3262)

Event Date 10/10/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 i was prescribed a cologuard test during a physical by my doctor.The cologuard test results came back negative for cancer or polyps, the test was wrong, i actually had cancer.I was one of eight people out of every one hundred people tested that had a false negative result, to put that in perspective out of five hundred thousand test given forty thousand people will be told they are cancer free when in fact they do have cancer, this number is to high.Cologuard was given fda approval for a dna based colon cancer screening test for very rural areas like alaska where people did not have access to colonoscopy's, once approval was granted they used the courts to gain market share and has since become used widespread.My doctor prescribed cologuard for me and did not explain the 14% false positive or the 8% false negative results (said he was unaware they were that high), in cologuard commercials they talk about false results but i think the average person thinks the numbers are like fractions of one percent, who would think they could get fda approval with a 20% failure rate when cologuard gives a negative test result they write a negative test means you are 1/1500 likely to have cancer less than 99.9% and yet their false negative rate is 8%, this is misleading.Doctors are prescribing cologuard without telling of the dangers of using cologuard.The reason my doctor prescribed cologuard was because it was faster than waiting for a colonoscopy, they do colonoscopy's in the same building, it was not like i had no access to one, by prescribing cologuard to me without telling me of their failure rate, my doctor all most killed me.In (b)(6) of 2021 i was diagnosed with stage iii rectal cancer after the tumor caused a blockage , that pathology showed i had for a number of years before the cologuard test, i underwent chemotherapy, radiation and surgery to have my rectum and sigmoid colon removed as well as 10 lymph nodes and will need a colostomy bag the rest of my life.Cologuard did not give me cancer, but it cost me two years where the cancer was getting worse and spreading.My oncologist told me had i had a colonoscopy instead of cologuard the colonoscopy would have found my cancer and it could have been treated with surgery only, and no long term effects.I was also told that had i waited the three years for my next test my cancer would have been fatal.Cologuard would be a great product for areas where you can not get a colonoscopy, and that is the reason for their fda approval, but they are now advertising on tv and hiring actors to promote their product.Remember, for every 100 people who use cologuard and get a negative result, 8 of them will have cancer and 14 will be told they have cancer when they don't which will require a colonoscopy to verify, that is more than 1 in 5 or 20% people getting wrong results.We would never allow 20% of any other medical test to be wrong, why do we allow this? cologuard needs to go back to what they were given their fda approval for and only be used where there is no access to colonoscopy's.There is no reason to use cologuard when colonoscopy's are so available in most places, they are marketing the convenience and not telling of the dangers.Cologuard is now a billion dollar company and getting a huge market share of colonoscopy's, but remember for every million tests they do, 80,000 people will be told they are cancer free when in fact they have cancer.Cologuard needs to lose their fda approval for widespread use unless they can improve their product, their 80% accuracy would probably be acceptable in areas where colonoscopy's are unavailable like rural alaska, but not in areas where colonoscopy's are so available.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 CORP
• MDR Report Key: 15455124
• MDR Text Key: 300326176
• Report Number: MW5112127
• 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: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: COLOSTOMY BAG
• Patient Outcome(s): Life Threatening; Disability; Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White