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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
COLLABORATIVEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
DIMENSIONAL DOSING SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELI LILLY AND CO.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DECISIONS NETWORK
  SUBSTANTIALLY EQUIVALENT 1
PRONIA MEDICAL SYSTEM, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect software programming calculations 34
Dose calculation error due to software problem 10
Inaccurate delivery 9
Use of Device Issue 8
Device alarm system issue 6
Other (for use when an appropriate device code cannot be identified) 4
Inappropriate prompts 3
Computer software issue 3
Not audible alarm 2
Programming issue 2
Patient Data Issue 2
Application program issue 2
Installation-related problem 2
No Known Device Problem 2
Problem with software installation 1
Device Issue 1
Parameter calculation error due to software problem 1
Total Device Problems 92

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1 2
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diabetes Care, Inc. II May-01-2017
2 Roche Diabetes Care, Inc. II Jan-26-2017
3 Roche Diabetes Care, Inc. II Nov-16-2016

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