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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device interoperable automated glycemic controller
Definition An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.
Product CodeQJI
Regulation Number 862.1356
Device Class 2


Premarket Reviews
ManufacturerDecision
BETA BIONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
INSULET CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TANDEM DIABETES CARE, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 2
TIDEPOOL PROJECT
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 4 4
2023 26 26
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21 21
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Use of Device Problem 3 3
No Device Output 3 3
Defective Device 3 3
Communication or Transmission Problem 2 2
Inappropriate or Unexpected Reset 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Application Program Problem 1 1
Material Puncture/Hole 1 1
Failure to Deliver 1 1
Inaccurate Delivery 1 1
Device Alarm System 1 1
Complete Blockage 1 1
Computer Software Problem 1 1
Display or Visual Feedback Problem 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Wireless Communication Problem 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypoglycemia 26 26
Loss of consciousness 11 11
Convulsion/Seizure 11 11
No Clinical Signs, Symptoms or Conditions 10 10
Insufficient Information 4 4
Hyperglycemia 4 4
Confusion/ Disorientation 3 3
Bone Fracture(s) 1 1
Shaking/Tremors 1 1
Sleep Dysfunction 1 1
Pain 1 1
Dysphasia 1 1
Diabetic Ketoacidosis 1 1

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