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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

MDR Year MDR Reports MDR Events
2018 21 21
2019 18 18
2020 10 10
2021 11 11
2022 348 348
2023 169 169

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 270 270
Computer Software Problem 246 246
Application Program Problem: Dose Calculation Error 36 36
Appropriate Term/Code Not Available 26 26
Adverse Event Without Identified Device or Use Problem 6 6
Incorrect Software Programming Calculations 5 5
Break 4 4
No Apparent Adverse Event 4 4
Battery Problem 4 4
Patient Device Interaction Problem 4 4
Patient Data Problem 3 3
Communication or Transmission Problem 3 3
Grounding Malfunction 2 2
Data Problem 2 2
Defective Device 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Insufficient Flow or Under Infusion 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1
Failure to Align 1 1
Application Program Problem 1 1
Application Program Version or Upgrade Problem 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Device Alarm System 1 1
Decoupling 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Priming Problem 1 1
Problem with Software Installation 1 1
Unauthorized Access to Computer System 1 1
Connection Problem 1 1
Device Sensing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 504 504
No Consequences Or Impact To Patient 27 27
No Known Impact Or Consequence To Patient 16 16
Hyperglycemia 11 11
Insufficient Information 10 10
Hypoglycemia 6 6
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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