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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device medication management system, remote
Definition A remote medication management system provides a means for the patient's prescribed medications to be stored in a delivery unit; For a medical provider to remotely schedule the patient's prescribed medications; To provide notification to the patient when the prescribed medications are due to be taken; To release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command; And to provide to the medical provider a history of the event. The system is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic.
Product CodeNZH
Regulation Number 880.6315
Device Class 2


Premarket Reviews
ManufacturerDecision
INRANGE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 5 5
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Data Problem 4 4
Patient Data Problem 2 2
Application Program Problem 2 2
Device Operates Differently Than Expected 1 1
Packaging Problem 1 1
Fail-Safe Design Failure 1 1
Device Displays Incorrect Message 1 1
Application Program Problem: Medication Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Information 3 3

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