TEST COLOGUARD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-29 for TEST COLOGUARD manufactured by Exact Sciences Laboratories.

Event Text Entries

[113161948] A positive test result from the (b)(6) testing called cologuard, my drs were very concerned and subjected me to a double colonoscopy and a dng with both showing negative results. Positive cologuard test result required extensive evaluation procedures to verify that it was false. Could have been minimized if provider identified if it was blood or dna, lack of info provided in the final report to the drs contributed to add'l testing to verify that it was a false positive result. The (b)(6) testing called cologuard performed (b)(6) 2018 test type of stool dna-biomarkers with hemoglobin immunoassay and not state which one is applicable to me. Consequently the drs were concerned if it was dna then there must be some form of cancer in the colon subjected me to a double colonoscopy, on (b)(6) 2018 followed by a dng on (b)(6) 2018 day after fathers day, both tests showed negative for physical cancer. Upon receiving the report, i noted that the test report small print does not state if it was blood or dna so, i called (b)(6) and was told that they did not know, this info would have been helpful in the recommended physical examinations. There i am asking that you require (b)(6), in positive test only to put in the final report to the dr whether it was blood positive or dna. It is advertised as dna per dr (b)(6) discussion with me and a rep of (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5078187
MDR Report Key7654520
Date Received2018-06-29
Date of Event2018-04-06
Date Added to Maude2018-07-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameTEST COLOGUARD
Generic NameTEST COLOGUARD
Product CodePHP
Date Received2018-06-29
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerEXACT SCIENCES LABORATORIES
Manufacturer Address145 E. BADGER RD., STE 100 MADISON WI 53713 US 53713

Device Sequence Number: 1

Brand NameTEST COLOGUARD
Generic NameTEST COLOGUARD
Product CodePHP
Date Received2018-06-29
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerEXACT SCIENCE LABORATORIES
Manufacturer Address145 E. BADGER RD., STE 100 MADISON WI 53713 US 53713


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-06-29

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