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	2216	2216
Incorrect, Inadequate or Imprecise Result or Readings	558	568
Non Reproducible Results	359	359
Low Test Results	279	279
Image Display Error/Artifact	188	188
Display Difficult to Read	124	124
Adverse Event Without Identified Device or Use Problem	62	62
Circuit Failure	61	61
Device Difficult to Setup or Prepare	58	58
No Device Output	37	37
Lack of Maintenance Documentation or Guidelines	17	17
Output Problem	12	12
Display or Visual Feedback Problem	12	13
Improper or Incorrect Procedure or Method	9	9
High Readings	6	6
Failure to Power Up	6	6
Off-Label Use	6	6
Incorrect Measurement	5	5
Device Handling Problem	5	5
Inaccurate Information	5	5
Battery Problem	4	4
Device Markings/Labelling Problem	4	5
Erratic or Intermittent Display	4	4
Unexpected Therapeutic Results	4	4
Use of Device Problem	4	4
Low Readings	4	4
Device Contamination with Chemical or Other Material	3	3
Therapeutic or Diagnostic Output Failure	3	3
Misassembly by Users	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Calibration Problem	3	3
Insufficient Information	3	3
Loss of Data	2	2
Audible Prompt/Feedback Problem	2	2
Device Sensing Problem	2	2
Device Displays Incorrect Message	2	2
Application Program Problem	2	2
Shipping Damage or Problem	2	2
Contamination	2	2
Mechanical Problem	2	2
Unable to Obtain Readings	2	2
Failure to Transmit Record	2	2
Nonstandard Device	1	1
Crack	1	1
Degraded	1	1
Material Discolored	1	1
No Display/Image	1	1
False Positive Result	1	1
Device Alarm System	1	1
Inadequate or Insufficient Training	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3294	3304
No Consequences Or Impact To Patient	222	222
Insufficient Information	79	81
Stroke/CVA	25	25
Thrombosis/Thrombus	24	24
Ischemia Stroke	21	21
Transient Ischemic Attack	15	15
Coagulation Disorder	11	11
Thromboembolism	10	10
Hemorrhage/Bleeding	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	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
Loss of Vision	3	3
Hematuria	3	3
Unspecified Heart Problem	3	3
Balance Problems	3	3
Confusion/ Disorientation	3	3
Urinary Tract Infection	2	2
Headache	2	2
Cardiac Enzyme Elevation	2	2
Laceration(s)	2	2
Chest Pain	2	2
Intracranial Hemorrhage	2	2
Retinal Injury	2	2
Easy Bruising	2	2
Cognitive Changes	2	2
Ischemia	2	2
Epistaxis	1	1
Unspecified Nervous System Problem	1	1
Movement Disorder	1	1
Angina	1	1
Oversedation	1	1
Chills	1	1
Blood Loss	1	1
Anemia	1	1
Vomiting	1	1
Hernia	1	1
Mitral Valve Insufficiency/ Regurgitation	1	1
Dyspnea	1	1
Fall	1	1
Pain	1	1
Visual Impairment	1	1
Valvular Stenosis	1	1
Unspecified Kidney or Urinary Problem	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