TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
COAGUSENSE, INC.
	SUBSTANTIALLY EQUIVALENT	2
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	4544	4544
Incorrect, Inadequate or Imprecise Result or Readings	847	847
Non Reproducible Results	675	675
Low Test Results	566	566
Image Display Error/Artifact	342	342
Display Difficult to Read	178	178
Circuit Failure	91	91
Incorrect Measurement	75	75
Adverse Event Without Identified Device or Use Problem	47	47
Device Difficult to Setup or Prepare	46	46
No Device Output	35	35
High Readings	22	22
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
Nonstandard Device	8	8
Low Readings	7	7
Off-Label Use	6	6
Failure to Power Up	5	5
Insufficient Information	4	4
Inaccurate Information	4	4
Unexpected Therapeutic Results	4	4
Erratic or Intermittent Display	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Patient Data Problem	3	3
Loss of Data	3	3
Battery Problem	3	3
Use of Device Problem	3	3
Device Markings/Labelling Problem	3	3
Human-Device Interface Problem	3	3
Calibration Problem	3	3
Misassembly by Users	3	3
Failure to Transmit Record	2	2
Smoking	2	2
No Display/Image	2	2
Contamination	2	2
Device Displays Incorrect Message	2	2
Unable to Obtain Readings	2	2
Mechanical Problem	2	2
Audible Prompt/Feedback Problem	2	2
Date/Time-Related Software Problem	2	2
Melted	2	2
Device Sensing Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Computer Software Problem	2	2
Compatibility Problem	1	1
Electrical /Electronic Property Problem	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	3799	3799
No Clinical Signs, Symptoms or Conditions	3109	3109
Insufficient Information	79	79
No Known Impact Or Consequence To Patient	68	68
No Information	51	51
Coagulation Disorder	32	32
Stroke/CVA	24	24
Thrombosis/Thrombus	22	22
Ischemia Stroke	18	18
Transient Ischemic Attack	15	15
Thromboembolism	12	12
Hemorrhage/Bleeding	11	11
Atrial Fibrillation	10	10
Pulmonary Embolism	8	8
Gastrointestinal Hemorrhage	8	8
Hemorrhagic Stroke	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Speech Disorder	6	6
Dizziness	6	6
Pain	5	5
No Patient Involvement	5	5
Numbness	4	4
Thrombosis	4	4
Chest Pain	4	4
High Blood Pressure/ Hypertension	3	3
Thrombus	3	3
Myocardial Infarction	3	3
Hematuria	3	3
Balance Problems	3	3
Ischemia	3	3
Confusion/ Disorientation	3	3
Urinary Tract Infection	2	2
Respiratory Failure	2	2
Cardiac Enzyme Elevation	2	2
Unspecified Heart Problem	2	2
Valvular Stenosis	2	2
Laceration(s)	2	2
Fall	2	2
Angina	2	2
Patient Problem/Medical Problem	2	2
Apnea	2	2
Cognitive Changes	2	2
Test Result	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

Recalls
Manufacturer		Recall Class	Date Posted
1	Instrumentation Laboratory	II	May-10-2022
2	Instrumentation Laboratory	II	Nov-23-2021
3	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
4	Roche Diagnostics Operations, Inc.	II	Jan-07-2021
5	TERRIFIC CARE LLC	I	Feb-01-2019