TPLC - Total Product Life Cycle

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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
ACON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARKRAY INC.
	SUBSTANTIALLY EQUIVALENT	1
ARKRAY, INC.
	SUBSTANTIALLY EQUIVALENT	1
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
SIEMENS HEALTHCARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
TECO DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	3
TECO DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	107	107
Low Test Results	38	38
High Test Results	29	29
False Positive Result	28	28
Electrical /Electronic Property Problem	26	26
Smoking	24	24
Break	23	23
Nonstandard Device	22	22
Incorrect, Inadequate or Imprecise Result or Readings	14	14
Non Reproducible Results	13	13
Patient Data Problem	8	8
Incorrect Or Inadequate Test Results	7	7
Use of Device Problem	6	6
Missing Information	6	6
Data Problem	5	5
Power Problem	4	4
Device Markings/Labelling Problem	4	4
Device Operates Differently Than Expected	4	4
Out-Of-Box Failure	3	3
Defective Device	3	3
Loss of Power	3	3
Failure to Power Up	3	3
Display Difficult to Read	3	3
Failure To Run On AC/DC	3	3
Computer Software Problem	2	2
Display or Visual Feedback Problem	2	2
Loose or Intermittent Connection	2	2
Device Difficult to Setup or Prepare	2	2
Mechanical Problem	2	2
Device Stops Intermittently	2	2
Device Displays Incorrect Message	2	2
Sparking	2	2
Optical Problem	2	2
Computer Operating System Problem	2	2
Connection Problem	1	1
High Readings	1	1
Low Readings	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Programming Issue	1	1
Temperature Problem	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Device Handling Problem	1	1
Missing Test Results	1	1
Calibration Problem	1	1
Device Damaged Prior to Use	1	1
Inadequate Service	1	1
Incorrect Measurement	1	1
Device Emits Odor	1	1
No Device Output	1	1
Overheating of Device	1	1
Unsealed Device Packaging	1	1
Power Conditioning Problem	1	1
Burst Container or Vessel	1	1
False Reading From Device Non-Compliance	1	1
Fire	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	200	200
No Known Impact Or Consequence To Patient	84	84
No Clinical Signs, Symptoms or Conditions	52	52
No Patient Involvement	26	26
Pregnancy	5	5
Not Applicable	3	3
Insufficient Information	2	2
Patient Problem/Medical Problem	1	1
Urinary Frequency	1	1
Distress	1	1
Exposure to Body Fluids	1	1
Irritation	1	1
Urinary Tract Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	Jan-13-2016
2	Roche Diagnostics Operations, Inc.	II	Oct-25-2016
3	Siemens Healthcare Diagnostics, Inc	II	Oct-17-2014