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 SAS
	SUBSTANTIALLY EQUIVALENT	1
ILINE MICROSYSTEMS S.L.
	SUBSTANTIALLY EQUIVALENT	3
INSTRUMENTATION LABORATORY CO.
	SUBSTANTIALLY EQUIVALENT	1
UNIVERSAL BIOSENSORS PTY LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	2864	2865
Incorrect, Inadequate or Imprecise Result or Readings	789	789
Non Reproducible Results	410	410
Low Test Results	391	391
Image Display Error/Artifact	235	235
Display Difficult to Read	178	178
Circuit Failure	94	94
Incorrect Measurement	75	75
Adverse Event Without Identified Device or Use Problem	54	54
Device Difficult to Setup or Prepare	48	48
No Device Output	39	39
High Readings	19	19
Display or Visual Feedback Problem	18	18
Lack of Maintenance Documentation or Guidelines	16	16
Output Problem	10	10
Improper or Incorrect Procedure or Method	9	9
Device Handling Problem	8	8
Failure to Power Up	6	6
Off-Label Use	6	6
Inaccurate Information	5	5
Low Readings	5	5
Device Markings/Labelling Problem	4	4
Battery Problem	4	4
Use of Device Problem	4	4
Unexpected Therapeutic Results	4	4
Erratic or Intermittent Display	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Insufficient Information	3	3
Human-Device Interface Problem	3	3
Device Displays Incorrect Message	3	3
Loss of Data	3	3
Calibration Problem	3	3
Misassembly by Users	3	3
Device Contamination with Chemical or Other Material	3	3
Failure to Transmit Record	2	2
Contamination	2	2
Unable to Obtain Readings	2	2
Audible Prompt/Feedback Problem	2	2
Mechanical Problem	2	2
Computer Software Problem	2	2
No Display/Image	2	2
Device Sensing Problem	2	2
Electrical /Electronic Property Problem	1	1
Overheating of Device	1	1
Inadequate or Insufficient Training	1	1
Nonstandard Device	1	1
Melted	1	1
Appropriate Term/Code Not Available	1	1
Power Problem	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3194	3195
No Consequences Or Impact To Patient	1533	1533
Insufficient Information	80	80
No Known Impact Or Consequence To Patient	31	31
Stroke/CVA	23	23
Coagulation Disorder	23	23
Thrombosis/Thrombus	23	23
Ischemia Stroke	19	19
Transient Ischemic Attack	14	14
Thromboembolism	10	10
Hemorrhage/Bleeding	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Pulmonary Embolism	8	8
Gastrointestinal Hemorrhage	8	8
Hemorrhagic Stroke	8	8
Speech Disorder	6	6
Dizziness	6	6
Atrial Fibrillation	6	6
No Information	5	5
Numbness	4	4
Balance Problems	3	3
Ischemia	3	3
No Patient Involvement	3	3
Confusion/ Disorientation	3	3
Urinary Tract Infection	2	2
Thrombus	2	2
Cardiac Enzyme Elevation	2	2
Unspecified Heart Problem	2	2
Laceration(s)	2	2
Chest Pain	2	2
Intracranial Hemorrhage	2	2
Patient Problem/Medical Problem	2	2
Cognitive Changes	2	2
Hematuria	2	2
Bruise/Contusion	1	1
Abdominal Pain	1	1
Quadriplegia	1	1
Low Blood Pressure/ Hypotension	1	1
Pulmonary Hypertension	1	1
Melena	1	1
Loss of Vision	1	1
Headache	1	1
Fainting	1	1
Wound Dehiscence	1	1
Arrhythmia	1	1
Respiratory Distress	1	1
Sepsis	1	1
Blurred Vision	1	1
Phlebitis	1	1
Myocardial Infarction	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