TPLC - Total Product Life Cycle

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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

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	2213	2213
Incorrect, Inadequate or Imprecise Result or Readings	556	566
Non Reproducible Results	335	335
Low Test Results	279	279
Image Display Error/Artifact	188	188
Display Difficult to Read	124	124
Circuit Failure	61	61
Adverse Event Without Identified Device or Use Problem	61	61
Device Difficult to Setup or Prepare	55	55
No Device Output	37	37
Lack of Maintenance Documentation or Guidelines	17	17
Display or Visual Feedback Problem	12	13
Output Problem	11	11
Improper or Incorrect Procedure or Method	9	9
Off-Label Use	6	6
Failure to Power Up	6	6
High Readings	6	6
Inaccurate Information	5	5
Incorrect Measurement	5	5
Unexpected Therapeutic Results	4	4
Erratic or Intermittent Display	4	4
Low Readings	4	4
Device Handling Problem	4	4
Use of Device Problem	4	4
Battery Problem	4	4
Device Markings/Labelling Problem	4	5
Manufacturing, Packaging or Shipping Problem	3	3
Calibration Problem	3	3
Misassembly by Users	3	3
Insufficient Information	3	3
Device Contamination with Chemical or Other Material	3	3
Unable to Obtain Readings	2	2
Shipping Damage or Problem	2	2
Contamination	2	2
Therapeutic or Diagnostic Output Failure	2	2
Audible Prompt/Feedback Problem	2	2
Failure to Transmit Record	2	2
Device Sensing Problem	2	2
Application Program Problem	2	2
Device Displays Incorrect Message	2	2
Loss of Data	2	2
Mechanical Problem	2	2
Degraded	1	1
Fail-Safe Problem	1	1
Patient Data Problem	1	1
Material Integrity Problem	1	1
Material Discolored	1	1
Component Missing	1	1
Material Twisted/Bent	1	2
Defective Component	1	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3268	3278
No Consequences Or Impact To Patient	222	222
Insufficient Information	79	81
Stroke/CVA	25	25
Thrombosis/Thrombus	23	23
Ischemia Stroke	20	20
Transient Ischemic Attack	15	15
Thromboembolism	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Coagulation Disorder	9	9
Hemorrhage/Bleeding	9	9
Gastrointestinal Hemorrhage	8	8
Hemorrhagic Stroke	8	8
Dizziness	7	7
Atrial Fibrillation	7	7
Pulmonary Embolism	6	6
Speech Disorder	6	6
Numbness	4	4
Balance Problems	3	3
Hematuria	3	3
Unspecified Heart Problem	3	3
Confusion/ Disorientation	3	3
Laceration(s)	2	2
Chest Pain	2	2
Intracranial Hemorrhage	2	2
Easy Bruising	2	2
Cardiac Enzyme Elevation	2	2
Cognitive Changes	2	2
Ischemia	2	2
Headache	2	2
Loss of Vision	2	2
Urinary Tract Infection	2	2
Fainting	1	1
Phlebitis	1	1
Myocardial Infarction	1	1
Blurred Vision	1	1
Cough	1	1
Low Blood Pressure/ Hypotension	1	1
Quadriplegia	1	1
Valvular Stenosis	1	1
Fall	1	1
Dyspnea	1	1
Bruise/Contusion	1	1
Visual Impairment	1	1
Pain	1	1
Unspecified Kidney or Urinary Problem	1	1
Hernia	1	1
Vomiting	1	1
Mitral Valve Insufficiency/ Regurgitation	1	1
Oversedation	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