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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EMR MEDICAL DEVICE DATA SYSTEM

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EMR MEDICAL DEVICE DATA SYSTEM Back to Search Results
Device Problem Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Description
I am reporting a series of events related to the use of vancomycin. My institution uses precision dosing software to calculate optimal vancomycin doses. This software is not integrated or interfaced with the emr. It requires manual data entry (entering labs, medication doses, demographic information) in order to calculate doses. In a review of 86 patient courses, data entry errors occurred 17% (15). This resulted in 3% (3) of patients receiving inappropriate doses. There was no clear harm to the patient as a result of these errors. (b)(4).
 
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Brand NameEMR
Type of DeviceMEDICAL DEVICE DATA SYSTEM
MDR Report Key12908711
MDR Text Key281739999
Report NumberMW5105691
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 08/03/2021
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

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