TPLC - Total Product Life Cycle

• 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