MAUDE MDR 2897169

MDR report key
2897169
Report number
2897169
Event key
0
Event type
3
Date of event
2012-12-11
Date received
2012-12-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MAGVIEWCOMPUTER ASSISTED DIAGNOSIS SOFTWARE, ULTRASOUND, BREASTMAGVIEWPAA*** Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-12-190

Event Narratives#

D

Patient 1

WHEN WE IMPLEMENTED MAG VIEW AS OUR NEW MAMMOGRAPHY REPORTING SYSTEM BACK ON FEBRUARY 06, 2012; THE SYSTEM HAD A GAIL RISK ASSESSMENT TOOL THAT WAS ALREADY A PART OF THE SOFTWARE. THIS RISK ASSESSMENT TOOL ALLOWS THE RADIOLOGISTS TO DETERMINE WHAT PERCENTAGE OF RISK BASED ON FAMILY, AND PERSONAL HISTORY OF A PATIENT. THIS RISK PERCENTAGE IS USED TO DETERMINE IF A PATIENT IS ELIGIBLE FOR MRI AS A HIGH RISK SCREENING TOOL.WE ADDED A SOFTWARE CALLED TYRER CUSZIK TO MAG VIEW THAT WOULD ALLOW US TO CAPTURE 100 PERCENT OF OUR SCREENING PATIENT POPULATION.ONCE WE IMPLEMENTED THIS MODEL IN ADDITION TO THE GAIL MODEL IN MAG VIEW, WE STARTED USING THIS DATA TO IDENTIFY ANY PATIENTS THAT NEED FOLLOW UP CALLS FROM HER FOR PREVENTATIVE TREATMENT.ONCE WE STARTED RUNNING REPORTS WE NOTICED THAT SOME OF THE DATA WAS NOT MAKING SENSE WHEN COMPARING PATIENTS' HISTORY WITH RISK FACTOR PERCENTAGES GENERATED BY THE GAIL SOFTWARE, SO WE SPOKE TO THE RADIOLOGIST WHO AGREED AND MAG VIEW WHO THEN STATED THAT THE ISSUE WAS A USER ISSUE NOT A SOFTWARE ISSUE. WE THEN PULLED 20 RANDOM CASES AND COMPARED THEM TO NCI GAIL VS. MAG VIEW GAIL VS. BRACA GAIL ONLY TO FIND THAT MAG VIEW DID NOT MATCH EITHER NCI OR BRACA.WHEN WE POINTED THIS OUT TO MAG VIEW WE WERE TOLD THAT WE ARE NOT READING THE NUMBERS CORRECTLY, OR WE DID NOT ENTER THE DATA CORRECTLY. WE THEN ASKED MAG VIEW WHAT VERSION OF GAIL ARE THEY USING NCI OR BRACA, AND THEY HAVE YET TO ANSWER THAT QUESTION.