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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
Regulation Description Predictive pulmonary-function value calculator.
Product CodeNDC
Regulation Number 868.1890
Device Class 2


Premarket Reviews
ManufacturerDecision
AMALGAM RX, INC
  SUBSTANTIALLY EQUIVALENT 1
COMPANION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
GNC HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC MINIMED
  SUBSTANTIALLY EQUIVALENT 1
MONARCH MEDICAL TECHNOLOGIES
  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
2020 10 10
2021 11 11
2022 348 348
2023 462 462
2024 168 168
2025 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 605 605
Computer Software Problem 384 384
Appropriate Term/Code Not Available 53 53
Break 18 18
Patient Device Interaction Problem 16 16
Application Program Problem: Dose Calculation Error 10 10
Insufficient Flow or Under Infusion 9 9
Battery Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Material Too Rigid or Stiff 4 4
No Apparent Adverse Event 4 4
Communication or Transmission Problem 3 3
Failure to Align 3 3
Unauthorized Access to Computer System 3 3
Data Problem 3 3
Priming Problem 3 3
Fluid/Blood Leak 3 3
Defective Device 2 2
Grounding Malfunction 2 2
Device Alarm System 1 1
Application Program Problem 1 1
Application Program Version or Upgrade Problem 1 1
Patient Data Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Problem with Software Installation 1 1
Use of Device Problem 1 1
Obstruction of Flow 1 1
Excess Flow or Over-Infusion 1 1
Infusion or Flow Problem 1 1
Product Quality Problem 1 1
Device Sensing Problem 1 1
Fracture 1 1
Inaccurate Delivery 1 1
Application Network Problem 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 979 979
Hyperglycemia 16 16
Insufficient Information 11 11
Hypoglycemia 8 8
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 3 3
Diabetic Ketoacidosis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Ulcer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Companion Medical, Inc. II Dec-20-2022
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