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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
COMPANION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
GNC HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K221924  Digital Routines
HYGIEIA, INC
  SUBSTANTIALLY EQUIVALENT 1
MONARCH MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 3
VOLUNTIS SA.
  SUBSTANTIALLY EQUIVALENT 1
VOLUNTIS, S.A.
  SUBSTANTIALLY EQUIVALENT 1
WELLDOC, INC
  SUBSTANTIALLY EQUIVALENT 1
WELLDOC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 18 18
2020 10 10
2021 11 11
2022 348 348
2023 462 462
2024 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 570 570
Computer Software Problem 373 373
Appropriate Term/Code Not Available 50 50
Application Program Problem: Dose Calculation Error 23 23
Break 16 16
Patient Device Interaction Problem 10 10
Insufficient Flow or Under Infusion 9 9
Battery Problem 6 6
Adverse Event Without Identified Device or Use Problem 4 4
No Apparent Adverse Event 4 4
Material Too Rigid or Stiff 4 4
Failure to Align 3 3
Unauthorized Access to Computer System 3 3
Communication or Transmission Problem 3 3
Connection Problem 2 2
Patient Data Problem 2 2
Defective Device 2 2
Use of Device Problem 2 2
Fluid/Blood Leak 2 2
Grounding Malfunction 2 2
Excess Flow or Over-Infusion 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Alarm System 1 1
Decoupling 1 1
Fracture 1 1
Improper or Incorrect Procedure or Method 1 1
Application Program Problem 1 1
Application Program Version or Upgrade Problem 1 1
Priming Problem 1 1
Data Problem 1 1
Device Sensing Problem 1 1
Problem with Software Installation 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 925 925
No Consequences Or Impact To Patient 17 17
Hyperglycemia 12 12
Insufficient Information 11 11
No Known Impact Or Consequence To Patient 8 8
Hypoglycemia 5 5
Ulcer 1 1
Diabetic Ketoacidosis 1 1
Death 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
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