TPLC - Total Product Life Cycle

• Device: nitroprusside, ketones (urinary, non-quant.)
• Regulation Description: Ketones (nonquantitative) test system.
• Product Code: JIN
• Regulation Number: 862.1435
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
I-SENS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VIVACHEK BIOTECH (HANGZHOU) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	37	37
2021	43	43
2022	14	14
2023	17	17
2024	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Discolored	55	55
No Device Output	39	39
Unsealed Device Packaging	20	20
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Unexpected Color	4	4
Labelling, Instructions for Use or Training Problem	4	4
Manufacturing, Packaging or Shipping Problem	2	2
Product Quality Problem	2	2
Output Problem	1	1
Device Markings/Labelling Problem	1	1
Insufficient Information	1	1
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Contamination	1	1
High Test Results	1	1
Device Emits Odor	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	54	54
No Consequences Or Impact To Patient	46	46
Insufficient Information	14	14
Fatigue	1	1
Nausea	1	1
Diabetic Ketoacidosis	1	1
No Known Impact Or Consequence To Patient	1	1
Injury	1	1
Vomiting	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Diabetes Care, Inc.	II	Feb-28-2020
2	Cardinal Health Inc.	II	May-20-2020
3	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-14-2022
4	Medline Industries Inc	II	Apr-09-2021
5	Stanbio Laboratory, LP	II	Dec-06-2023
6	Stanbio Laboratory, LP	III	Aug-05-2021
7	Universal Meditech Inc.	II	Oct-23-2023