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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

Device Problems
Application Program Problem: Dose Calculation Error 42
Incorrect Software Programming Calculations 33
Computer Software Problem 5
Data Problem 3
Patient Data Problem 3
Programming Issue 2
Application Program Problem 2
Connection Problem 1
Device Operational Issue 1
Adverse Event Without Identified Device or Use Problem 1
Problem with Software Installation 1
Decoupling 1
Application Program Problem: Parameter Calculation Error 1
Use of Device Problem 1
Improper or Incorrect Procedure or Method 1
Device Issue 1
Total Device Problems 99

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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