SURESCRIPTS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-26 for SURESCRIPTS manufactured by .

Event Text Entries

[53673238] Description: main error: dangerously high insulin glargine dose entered, transferred from an external pharmacy via electronic medical record (emr) information sharing from outside sources (in this case, a surescripts interface). The event was caused by the dose present on the patient's prior to admission insulin glargine order from an outside pharmacy. This was caused by the sig on the outpatient prescription being "100 ml", and this information subsequently being automatically forwarded to the emr information sharing from outside sources. This external pharmacy reported medication was created in our system on (b)(6) 2016 during medication history review by a certified medical assistant, where the "dose" was 100 ml pulled forward from this outpatient sig and the emr converted it to 10,000 units. The order was modified on 05/23, but the "100 ml" discrete dose was not removed (nurse added more free texted instructions, but didn't change the dose in discrete fields). When the order was "continued" as an inpatient order, the discrete dose of 10,000 units was carried forward to that order. This was ordered by the physician. In this situation nursing identified the error prior to pharmacy verification and before any doses were dispensed or the patient received the medication. This event is perhaps easy to recognize and easy to identify as a medication event with this huge volume of insulin glargine, but with a smaller variation this could go unnoticed and have concerning consequences. We would like to raise awareness to all pharmacists that electronic information is being shared across systems, both health systems and community pharmacy. Awareness of the importance of accurate patient instructions is paramount. The following files are included with this submission. Medication administered to or used by the patient: no. When and how was error discovered: in this situation nursing identified the error prior to pharmacy verification and before any doses were dispensed or the patient received the medication. Patient counselling provided: unk. Reporter's recommendations: this event is perhaps easy to recognize and easy to identify as a medication event with this huge volume of insulin glargine, but with a smaller variation this could go unnoticed and have concerning consequences. We would like to raise awareness to all pharmacists that electronic information is being shared across systems, both health system and community pharmacy. Awareness of the importance of accurate patient instructions is paramount. The following files are included with this submission. Medication administered to or used by the patient: no. When and how was error discovered: in this situation nursing identified the error prior to pharmacy verification and before any doses were dispensed or the patient received the medication. Patient counseling provided: unk. Reporter's recommendations: this event is perhaps easy to recognize and easy to identify as a medication event with this high volume of insulin glargin, but with a smaller variation this could go unnoticed and have concerning consequences. We would like to raise awareness to all pharmacists that electronic information is being shared across systems, both health-system and community pharmacy. Awareness of the importance of accurate patient instructions is paramount. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5064433
MDR Report Key5913422
Date Received2016-08-26
Date of Event2016-06-30
Date Added to Maude2016-08-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSURESCRIPTS
Generic NameSURESCRIPTS
Product CodeNZH
Date Received2016-08-26
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-26

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