AMBULATORY CARE SYSTEM (ECLINICALWORKS OR ECW)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-08 for AMBULATORY CARE SYSTEM (ECLINICALWORKS OR ECW) manufactured by .

Event Text Entries

[5251906] We discovered two significant pt safety issues that could cause a provider to order the wrong type of insulin. The first concerns a design flaw that allows one to erroneously order u-500 insulin in our ambulatory care electronic medical record system. Currently, when one goes to order regular insulin in our ambulatory care system (eclinicalworks or ecw), both insulin r u-100 and insulin r u-500 pop up. Upon typing in "insulin r" one gets two options: "insulin regular human" and "insulin regular human con". Presumably the part that is cut off refers to concentrated to indicate it is the u-500 insulin. However "con" could refer to any number of things and in any case that terminology is non-standard and non-specific as to what that option is. Thus not only is it not clearly labeled or clear what the second option is, but also given that they pop up together, it would be very easy to erroneously select the concentrated version. This has already happened when providers are building a med list for the pt, but so far, no erroneous prescriptions have been found. Given u-500 insulin is five times as strong, if it was prescribed in error, it would be very easy for a pt to overdose on the insulin resulting in a potentially fatal hypoglycemic event. The second issue involves the use of th e term insulin isophane for both nph and 70/30 insulin. This is a term not in the standard prescription lexicon in the united states. The use of this unfamiliar term has resulted in inappropriate prescription of nph insulin when r was intended because providers assumed isophane was r. One example where this happened was a pt who previously was taking lantus qhs and insulin regular before breakfast. But when data was moved to eclinicalworks, the regular insulin got switched to insulin isophane and she's been getting that ever since. Because providers aren't used to seeing insulin isophane it was missed for over a year, and the pharmacy didn't catch it. Her bgs are generally very high, but she has had bgs in the 50s that may be due to receiving nph instead or r. Possible solutions include changing any reference of isophane to nph in all instances and changing u-500 insulin r to perhaps start with u-500 rather than insulin so it doesn't pop up immediately with insulin r. Our ecw vendor contracts with (b)(4) to provide the pharmacy info, and this is a potential problem for all emrs that contract with (b)(4) for their pharmacy info. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5039446
MDR Report Key4323028
Date Received2014-12-08
Date of Report2014-10-07
Date Added to Maude2014-12-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameAMBULATORY CARE SYSTEM (ECLINICALWORKS OR ECW)
Generic NameELECTRONIC MEDICAL RECORD SYSTEM
Product CodeNSX
Date Received2014-12-08
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2014-12-08

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