SOARIAN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-28 for SOARIAN manufactured by Siemens.

Event Text Entries

[1747210] We present this report as an example of error facilitated by deficient human factor development of medical device data system screens that display results of lab tests on an ehr. The spread sheet listing the tests by line on the left hand column y axis has the dates displayed across the top x axis. The error promoting layout deficiency is that a column does not represent the same date from the test listed first, at the top, to the test listed last, at the bottom. If a particular test was not performed on a certain day, there is not any visual representation, such as a blank space for that date, that it was not done on that date. For the pt, hospitalized for failure to thrive, subject to this complaint who was prescribed coumadin for thrombophilia syndrome, the most recent inr test was approx 2 weeks old and was an outpatient test, but appeared in the column for the date of the most recent in hospital blood chemistry result, giving the illusion on quick glance that it was a recent result. The coumadin was prescribed based on an outdated test and resulted in an inr that became dangerously high, triggering the need for parenteral vitamin k. The pt did not bleed and has lived happily ever after an extra day in the hospital. We believe that the defect facilitating obfuscation of the date a test was done in relation to all other lab tests, and the defect comingling or failing to identify an outpatient test apart from an inpatient test, generates innumerable errors. There is not any record being kept of this, to our knowledge.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5018595
MDR Report Key1931377
Date Received2010-11-28
Date of Report2010-11-28
Date of Event2010-11-20
Date Added to Maude2010-12-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSOARIAN
Generic NameEHR LAB DISPLAY
Product CodeLMD
Date Received2010-11-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS
Manufacturer AddressMALVERN PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other 2010-11-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.