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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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 599 599
Computer Software Problem 384 384
Appropriate Term/Code Not Available 53 53
Break 18 18
Patient Device Interaction Problem 14 14
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
Unauthorized Access to Computer System 3 3
Failure to Align 3 3
Priming Problem 2 2
Defective Device 2 2
Grounding Malfunction 2 2
Fluid/Blood Leak 2 2
Device Sensing Problem 1 1
Connection Problem 1 1
Problem with Software Installation 1 1
Inaccurate Delivery 1 1
Product Quality Problem 1 1
Device Alarm System 1 1
Excess Flow or Over-Infusion 1 1
Obstruction of Flow 1 1
Application Network Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Application Program Version or Upgrade Problem 1 1
Use of Device Problem 1 1
Fracture 1 1
Application Program Problem 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 970 970
Hyperglycemia 15 15
Insufficient Information 11 11
Hypoglycemia 6 6
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 3 3
Diabetic Ketoacidosis 2 2
Death 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Ulcer 1 1

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