TPLC - Total Product Life Cycle

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Device	visual, pregnancy hcg, prescription use
Regulation Description	Human chorionic gonadotropin (HCG) test system.
Product Code	JHI
Regulation Number	862.1155
Device Class	2

Premarket Reviews
Manufacturer	Decision
ASSURE TECH. CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
TRUE DIAGNOSTICS, INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	563	563
False Negative Result	472	472
Incorrect, Inadequate or Imprecise Resultor Readings	83	83
Adverse Event Without Identified Device or Use Problem	36	36
Incorrect Or Inadequate Test Results	34	34
No Apparent Adverse Event	22	22
High Test Results	10	10
Insufficient Information	4	4
Non Reproducible Results	4	4
Low Test Results	2	2
Device Ingredient or Reagent Problem	1	1
Device Operates Differently Than Expected	1	1
Use of Device Problem	1	1
Device Issue	1	1
Output Problem	1	1
Display Difficult to Read	1	1
No Display/Image	1	1
Display or Visual Feedback Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	707	707
No Known Impact Or Consequence To Patient	165	165
No Information	116	116
No Clinical Signs, Symptoms or Conditions	100	100
Insufficient Information	77	77
No Code Available	27	27
Ectopic Pregnancy	7	7
Pregnancy	6	6
Miscarriage	5	5
Patient Problem/Medical Problem	5	5
Abdominal Pain	4	4
Misdiagnosis	3	3
Test Result	3	3
Radiation Exposure, Unintended	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Patient Involvement	2	2
Distress	2	2
Cyst(s)	2	2
Menstrual Irregularities	2	2
Dyspnea	1	1
Nausea	1	1
Urinary Tract Infection	1	1
Vomiting	1	1
Weight Changes	1	1
Rupture	1	1
Anxiety	1	1
Intermenstrual Bleeding	1	1