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	3
INSTRUMENTATION LABORATORY CO
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
UNIVERSAL BIOSENSORS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	1359	1370
2022	1210	1211
2023	809	809
2024	177	178
2025	106	106
2026	103	103

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	2219	2220
Incorrect, Inadequate or Imprecise Result or Readings	545	545
Non Reproducible Results	389	389
Low Test Results	281	281
Image Display Error/Artifact	189	189
Display Difficult to Read	124	124
Adverse Event Without Identified Device or Use Problem	66	66
Device Difficult to Setup or Prepare	66	66
Circuit Failure	61	61
No Device Output	39	39
Lack of Maintenance Documentation or Guidelines	18	18
Output Problem	12	12
Improper or Incorrect Procedure or Method	9	9
Display or Visual Feedback Problem	9	9
Failure to Power Up	7	7
Off-Label Use	6	6
Incorrect Measurement	6	6
Inaccurate Information	5	5
Device Handling Problem	5	5
High Readings	5	5
Battery Problem	5	5
Use of Device Problem	5	5
Unexpected Therapeutic Results	4	4
Erratic or Intermittent Display	4	4
Device Contamination with Chemical or Other Material	4	4
Low Readings	4	4
Misassembly by Users	4	4
Insufficient Device Problem Information	3	3
Calibration Problem	3	3
Contamination	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Device Markings/Labelling Problem	3	3
Device Displays Incorrect Message	3	3
Audible Prompt/Feedback Problem	2	2
Device Damaged Prior to Receipt by User	2	2
Device Sensing Problem	2	2
Failure to Transmit Record	2	2
Loss of Data	2	2
Fail-Safe Problem	1	1
Unable to Obtain Readings	1	1
Material Discolored	1	1
Component Missing	1	1
Degraded	1	1
Scratched Material	1	1
Environmental Compatibility Problem	1	1
Patient Data Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Integrity Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3338	3348
No Consequences Or Impact To Patient	222	222
Insufficient Information	81	83
Thrombosis/Thrombus	27	27
Stroke/CVA	25	25
Ischemia Stroke	21	21
Transient Ischemic Attack	16	16
Coagulation Disorder	11	11
Hemorrhage/Blood Loss/Bleeding	10	10
Thromboembolism	10	10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	9	9
Gastrointestinal Hemorrhage	8	8
Hemorrhagic Stroke	8	8
Pulmonary Embolism	7	7
Dizziness	7	7
Atrial Fibrillation	7	7
Speech Disorder	6	6
Numbness	4	4
Balance Problems	3	3
Unspecified Heart Problem	3	3
Confusion/ Disorientation	3	3
Loss of Vision	3	3
Hematuria	3	3
Easy Bruising	2	2
Retinal Injury	2	2
Cognitive Changes	2	2
Ischemia	2	2
Headache	2	2
Cardiac Enzyme Elevation	2	2
Intracranial Hemorrhage	2	2
Chest Pain	2	2
Urinary Tract Infection	2	2
Laceration(s)	2	2
Blurred Vision	1	1
Myocardial Infarction	1	1
Fainting	1	1
Cough	1	1
Low Blood Pressure/ Hypotension	1	1
Quadriplegia	1	1
Unspecified Kidney or Urinary Problem	1	1
Valvular Stenosis	1	1
Visual Impairment	1	1
Pain	1	1
Bruise/Contusion	1	1
Fall	1	1
Dyspnea	1	1
Mitral Valve Insufficiency/ Regurgitation	1	1
Hernia	1	1
Vomiting	1	1
Vasculitis	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