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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device calculator, drug dose
Product CodeNDC
Regulation Number 868.1890
Device Class 2


Premarket Reviews
ManufacturerDecision
AL PACHECO AND ASSOCIATES
  SUBSTANTIALLY EQUIVALENT 1
ALR TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COMPANION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
GLOOKO, INC
  SUBSTANTIALLY EQUIVALENT 1
GLYTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
HYGIEIA, INC
  SUBSTANTIALLY EQUIVALENT 1
INSULIN ALGORITHMS
  SUBSTANTIALLY EQUIVALENT 1
ISAG RX, INC.
  SUBSTANTIALLY EQUIVALENT 1
MONARCH MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 3
SANOFI
  SUBSTANTIALLY EQUIVALENT 1
SANOFI, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLUNTIS S.A.
  SUBSTANTIALLY EQUIVALENT 2
VOLUNTIS, S.A.
  SUBSTANTIALLY EQUIVALENT 1
WELLDOC, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 25 25
2018 21 21
2019 18 18
2020 10 10
2021 11 11
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Problem: Dose Calculation Error 46 46
Incorrect Software Programming Calculations 19 19
Computer Software Problem 8 8
Adverse Event Without Identified Device or Use Problem 4 4
Data Problem 3 3
Patient Data Problem 3 3
Programming Issue 2 2
No Apparent Adverse Event 2 2
Use of Device Problem 2 2
Defective Device 2 2
Application Program Problem 2 2
Grounding Malfunction 2 2
Application Program Problem: Parameter Calculation Error 1 1
Product Quality Problem 1 1
Device Inoperable 1 1
Decoupling 1 1
Fluid Leak 1 1
Application Program Version or Upgrade Problem 1 1
Connection Problem 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Material Integrity Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Issue 1 1
Problem with Software Installation 1 1
Patient Device Interaction Problem 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 38 38
No Known Impact Or Consequence To Patient 27 27
No Clinical Signs, Symptoms or Conditions 11 11
Hypoglycemia 5 5
Insufficient Information 4 4
Hyperglycemia 3 3
Death 2 2
Electrolyte Imbalance 2 2
Ulcer 1 1
Diabetic Ketoacidosis 1 1
Loss of consciousness 1 1
Headache 1 1
Cardiac Arrest 1 1
Nausea 1 1
Overdose 1 1
Seizures 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Monarch Medical Technologies II Nov-08-2019
2 Monarch Medical Technologies II Jun-15-2019
3 Roche Diabetes Care, Inc. II Sep-26-2019
4 Roche Diabetes Care, Inc. II Feb-15-2018
5 Roche Diabetes Care, Inc. II Dec-06-2017
6 Roche Diabetes Care, Inc. II May-01-2017
7 Roche Diabetes Care, Inc. II Jan-26-2017
8 Voluntis II Nov-17-2018
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