FDA Adverse Event Injury Summary report: N

SOARIAN

MDR report key: 1931377 · Received November 28, 2010

Report

Report Number
MW5018595
Event Type
Injury
Date Received
November 28, 2010
Date of Event
November 20, 2010
Report Date
November 28, 2010
Manufacturer
SIEMENS
Product Code
LMD
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

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 THE COUMADIN WAS PRESCRIBED BASED ON AN OUTDATED TEST AND RESULTED IN AN INR THAT BECAME DANGEROUSLY HIGH, TRIGGERING THE NEED FOR PARENTERAL VITAMIN K. THE PT DID NOT BLEED AND HAS LIVED HAPPILY EVER AFTER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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SOARIAN EHR LAB DISPLAY LMD SIEMENS

Patients

Seq Age Sex Outcome Treatment
1 80 YR Hospitalization| L| O