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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device calculator, drug dose
Regulation Description Predictive pulmonary-function value calculator.
Product CodeNDC
Regulation Number 868.1890
Device Class 2


Premarket Reviews
ManufacturerDecision
ALR TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ELI LILLY AND CO.
  SUBSTANTIALLY EQUIVALENT 1
ELI LILLY AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
GLYTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
INSULIN ALGORITHMS
  SUBSTANTIALLY EQUIVALENT 1
MONARCH MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIABETES CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 18 18
2017 25 25
2018 21 21
2019 18 18
2020 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Problem: Dose Calculation Error 44 44
Incorrect Software Programming Calculations 33 33
Computer Software Problem 5 5
Data Problem 3 3
Patient Data Problem 3 3
Programming Issue 2 2
Application Program Problem 2 2
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Decoupling 1 1
Display Difficult to Read 1 1
Application Program Problem: Parameter Calculation Error 1 1
Product Quality Problem 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Connection Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Problem with Software Installation 1 1
Use of Device Problem 1 1
Device Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 48 48
No Known Impact Or Consequence To Patient 30 30
Hypoglycemia 6 6
Death 3 3
Hyperglycemia 2 2
Electrolyte Imbalance 2 2
Complaint, Ill-Defined 1 1
Cardiac Arrest 1 1
Headache 1 1
Nausea 1 1
Overdose 1 1
Seizures 1 1
Vomiting 1 1
Renal Failure 1 1
Loss of consciousness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Monarch Medical Technologies II Nov-08-2019
2 Monarch Medical Technologies II Jun-15-2019
3 Roche Diabetes Care, Inc. II Sep-26-2019
4 Roche Diabetes Care, Inc. II Feb-15-2018
5 Roche Diabetes Care, Inc. II Dec-06-2017
6 Roche Diabetes Care, Inc. II May-01-2017
7 Roche Diabetes Care, Inc. II Jan-26-2017
8 Roche Diabetes Care, Inc. II Nov-16-2016
9 Voluntis II Nov-17-2018
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