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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calculator, drug dose
Product CodeNDC
Regulation Number 868.1890
Device Class 2


Premarket Reviews
ManufacturerDecision
AL PACHECO AND ASSOCIATES
  SUBSTANTIALLY EQUIVALENT 1
COMPANION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
GLOOKO, INC
  SUBSTANTIALLY EQUIVALENT 1
GNC HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HYGIEIA, INC
  SUBSTANTIALLY EQUIVALENT 1
MONARCH MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 3
VOLUNTIS, S.A.
  SUBSTANTIALLY EQUIVALENT 1
WELLDOC, INC
  SUBSTANTIALLY EQUIVALENT 1
WELLDOC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 21 21
2019 18 18
2020 10 10
2021 11 11
2022 348 348
2023 356 356

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 398 398
Computer Software Problem 307 307
Application Program Problem: Dose Calculation Error 36 36
Appropriate Term/Code Not Available 35 35
Break 13 13
Patient Device Interaction Problem 7 7
Insufficient Flow or Under Infusion 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Battery Problem 6 6
Incorrect Software Programming Calculations 5 5
No Apparent Adverse Event 4 4
Patient Data Problem 3 3
Communication or Transmission Problem 3 3
Failure to Align 3 3
Defective Device 2 2
Material Too Rigid or Stiff 2 2
Use of Device Problem 2 2
Fluid/Blood Leak 2 2
Grounding Malfunction 2 2
Connection Problem 2 2
Data Problem 2 2
Priming Problem 1 1
Device Sensing Problem 1 1
Problem with Software Installation 1 1
Unauthorized Access to Computer System 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1
Excess Flow or Over-Infusion 1 1
Fracture 1 1
Device Alarm System 1 1
Decoupling 1 1
Improper or Incorrect Procedure or Method 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Application Program Problem 1 1
Application Program Version or Upgrade Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 689 689
No Consequences Or Impact To Patient 27 27
No Known Impact Or Consequence To Patient 16 16
Hyperglycemia 12 12
Insufficient Information 11 11
Hypoglycemia 7 7
Death 2 2
Cardiac Arrest 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Seizures 1 1
Electrolyte Imbalance 1 1
Ulcer 1 1
Diabetic Ketoacidosis 1 1
Loss of consciousness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Companion Medical, Inc. II Dec-20-2022
2 Monarch Medical Technologies II Nov-08-2019
3 Monarch Medical Technologies II Jun-15-2019
4 Roche Diabetes Care, Inc. II Sep-26-2019
5 Roche Diabetes Care, Inc. II Feb-15-2018
6 Voluntis II Nov-17-2018
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