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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
CAMDIAB LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
INSULET CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
TANDEM DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
  GRANTED 1
TIDEPOOL PROJECT
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 4 4
2023 26 26
2024 15 15

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypoglycemia 27 27
Convulsion/Seizure 11 11
Loss of consciousness 11 11
No Clinical Signs, Symptoms or Conditions 10 10
Hyperglycemia 5 5
Insufficient Information 4 4
Confusion/ Disorientation 3 3
Dysphasia 1 1
Sleep Dysfunction 1 1
Diabetic Ketoacidosis 1 1
Bone Fracture(s) 1 1
Pain 1 1
Shaking/Tremors 1 1

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