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	2
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	2859	2860
Incorrect, Inadequate or Imprecise Result or Readings	787	787
Non Reproducible Results	394	394
Low Test Results	390	390
Image Display Error/Artifact	234	234
Display Difficult to Read	178	178
Circuit Failure	91	91
Incorrect Measurement	75	75
Adverse Event Without Identified Device or Use Problem	52	52
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
Off-Label Use	6	6
Low Readings	5	5
Failure to Power Up	5	5
Erratic or Intermittent Display	4	4
Device Markings/Labelling Problem	4	4
Unexpected Therapeutic Results	4	4
Inaccurate Information	4	4
Use of Device Problem	4	4
Misassembly by Users	3	3
Calibration Problem	3	3
Battery Problem	3	3
Human-Device Interface Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Insufficient Information	3	3
Loss of Data	3	3
Unable to Obtain Readings	2	2
Contamination	2	2
Audible Prompt/Feedback Problem	2	2
Failure to Transmit Record	2	2
Device Displays Incorrect Message	2	2
Computer Software Problem	2	2
Mechanical Problem	2	2
No Display/Image	2	2
Device Sensing Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Inadequate or Insufficient Training	1	1
Nonstandard Device	1	1
Melted	1	1
Overheating of Device	1	1
Appropriate Term/Code Not Available	1	1
Power Problem	1	1
Electrical /Electronic Property Problem	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	3167	3168
No Consequences Or Impact To Patient	1533	1533
Insufficient Information	80	80
No Known Impact Or Consequence To Patient	31	31
Thrombosis/Thrombus	23	23
Stroke/CVA	23	23
Coagulation Disorder	23	23
Ischemia Stroke	19	19
Transient Ischemic Attack	14	14
Hemorrhage/Bleeding	10	10
Thromboembolism	10	10
Hemorrhagic Stroke	8	8
Gastrointestinal Hemorrhage	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Pulmonary Embolism	7	7
Atrial Fibrillation	6	6
Dizziness	6	6
Speech Disorder	6	6
No Information	5	5
Numbness	4	4
Ischemia	3	3
Confusion/ Disorientation	3	3
No Patient Involvement	3	3
Balance Problems	3	3
Hematuria	2	2
Cardiac Enzyme Elevation	2	2
Cognitive Changes	2	2
Thrombus	2	2
Urinary Tract Infection	2	2
Unspecified Heart Problem	2	2
Intracranial Hemorrhage	2	2
Patient Problem/Medical Problem	2	2
Chest Pain	2	2
Laceration(s)	2	2
Headache	1	1
Loss of Vision	1	1
Fainting	1	1
Low Blood Pressure/ Hypotension	1	1
Quadriplegia	1	1
Phlebitis	1	1
Bruise/Contusion	1	1
Myocardial Infarction	1	1
Blurred Vision	1	1
Cough	1	1
Pneumonia	1	1
Valvular Stenosis	1	1
Fall	1	1
Dyspnea	1	1
Visual Impairment	1	1
Pain	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