MAGVIEW *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-19 for MAGVIEW * manufactured by Magview.

Event Text Entries

[16539152] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2897169
MDR Report Key2897169
Date Received2012-12-19
Date of Report2012-12-19
Date of Event2012-12-11
Report Date2012-12-19
Date Reported to FDA2012-12-19
Date Added to Maude2013-01-04
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMAGVIEW
Generic NameCOMPUTER ASSISTED DIAGNOSIS SOFTWARE, ULTRASOUND, BREAST
Product CodePAA
Date Received2012-12-19
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Device Age9 MO
Device Sequence No1
Device Event Key0
ManufacturerMAGVIEW
Manufacturer Address3915 NATIONAL DRIVE SUITE 200 BURTONSVILLE MD 20866 US 20866


Patients

Patient NumberTreatmentOutcomeDate
10 2012-12-19

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