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TPLC
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Device
method, enzymatic, glucose (urinary, non-quantitative)
Product Code
JIL
Regulation Number
862.1340
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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