TPLC - Total Product Life Cycle

• Device: test, time, prothrombin
• Regulation Description: Prothrombin time test.
• Product Code: GJS
• Regulation Number: 864.7750
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
COAGUSENSE, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIAGNOSTICA STAGO S.A.S
	SUBSTANTIALLY EQUIVALENT	1
ILINE MICROSYSTEMS, S.L.
	SUBSTANTIALLY EQUIVALENT	4
INSTRUMENTATION LABORATORY CO
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
UNIVERSAL BIOSENSORS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	1390	1393
2021	1359	1370
2022	1210	1211
2023	809	809
2024	177	178
2025	106	106
2026	11	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	2877	2877
Incorrect, Inadequate or Imprecise Result or Readings	798	811
Non Reproducible Results	465	465
Low Test Results	392	392
Image Display Error/Artifact	239	239
Display Difficult to Read	178	178
Circuit Failure	95	95
Incorrect Measurement	75	75
Adverse Event Without Identified Device or Use Problem	59	59
Device Difficult to Setup or Prepare	53	53
No Device Output	39	39
High Readings	19	19
Display or Visual Feedback Problem	18	19
Lack of Maintenance Documentation or Guidelines	16	16
Output Problem	11	11
Improper or Incorrect Procedure or Method	9	9
Device Handling Problem	8	8
Failure to Power Up	6	6
Off-Label Use	6	6
Low Readings	5	5
Inaccurate Information	5	5
Device Markings/Labelling Problem	4	5
Battery Problem	4	4
Erratic or Intermittent Display	4	4
Unexpected Therapeutic Results	4	4
Use of Device Problem	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Human-Device Interface Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Misassembly by Users	3	3
Loss of Data	3	3
Insufficient Information	3	3
Calibration Problem	3	3
Device Displays Incorrect Message	3	6
Device Sensing Problem	2	2
Application Program Problem	2	2
No Display/Image	2	2
Contamination	2	2
Computer Software Problem	2	2
Shipping Damage or Problem	2	2
Failure to Transmit Record	2	2
Unable to Obtain Readings	2	2
Mechanical Problem	2	2
Audible Prompt/Feedback Problem	2	2
Inadequate or Insufficient Training	1	1
Defective Component	1	7
Component Missing	1	1
Tear, Rip or Hole in Device Packaging	1	1
Device Alarm System	1	1
Thermal Decomposition of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3266	3276
No Consequences Or Impact To Patient	1533	1533
Insufficient Information	80	82
No Known Impact Or Consequence To Patient	31	34
Stroke/CVA	27	27
Coagulation Disorder	24	24
Thrombosis/Thrombus	23	23
Ischemia Stroke	20	20
Transient Ischemic Attack	15	15
Hemorrhage/Bleeding	10	10
Thromboembolism	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Pulmonary Embolism	9	9
Atrial Fibrillation	9	9
Hemorrhagic Stroke	8	8
Gastrointestinal Hemorrhage	8	8
Dizziness	7	7
Speech Disorder	6	6
No Information	5	5
Numbness	4	4
Hematuria	3	3
Ischemia	3	3
Confusion/ Disorientation	3	3
Unspecified Heart Problem	3	3
No Patient Involvement	3	3
Balance Problems	3	3
Headache	2	2
Cardiac Enzyme Elevation	2	2
Cognitive Changes	2	2
Thrombus	2	2
Easy Bruising	2	2
Urinary Tract Infection	2	2
Intracranial Hemorrhage	2	2
Patient Problem/Medical Problem	2	2
Chest Pain	2	2
Laceration(s)	2	2
Loss of Vision	1	1
Fainting	1	1
Low Blood Pressure/ Hypotension	1	1
Quadriplegia	1	1
Phlebitis	1	1
Bruise/Contusion	1	1
Myocardial Infarction	1	1
Blurred Vision	1	1
Cough	1	1
Pneumonia	1	1
Valvular Stenosis	1	1
Fall	1	1
Dyspnea	1	1
Visual Impairment	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Fisher Diagnostics	II	Mar-31-2025
2	Instrumentation Laboratory	II	May-10-2022
3	Instrumentation Laboratory	II	Nov-23-2021
4	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
5	Roche Diagnostics Operations, Inc.	II	Jan-07-2021