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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 method, enzymatic, glucose (urinary, non-quantitative)
Product CodeJIL
Regulation Number 862.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
DFI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEALTHY.IO LTD
  SUBSTANTIALLY EQUIVALENT 1
IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL INC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SCANADU, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 33 33
2018 68 68
2019 67 67
2020 23 23
2021 12 12
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 54 54
Low Test Results 33 33
High Test Results 29 29
Electrical /Electronic Property Problem 23 23
False Positive Result 21 21
Non Reproducible Results 12 12
Smoking 8 8
Missing Information 6 6
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Use of Device Problem 4 4
Patient Data Problem 4 4
Device Markings/Labelling Problem 2 2
Computer Software Problem 2 2
Display Difficult to Read 1 1
Leak/Splash 1 1
Incorrect Or Inadequate Test Results 1 1
Optical Problem 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Data Problem 1 1
Device Handling Problem 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 130 130
No Known Impact Or Consequence To Patient 26 26
No Patient Involvement 23 23
No Clinical Signs, Symptoms or Conditions 19 19
Pregnancy 5 5
Not Applicable 3 3
Patient Problem/Medical Problem 1 1
Urinary Frequency 1 1
Exposure to Body Fluids 1 1
Urinary Tract Infection 1 1
Insufficient Information 1 1

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