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	2209	2209
Incorrect, Inadequate or Imprecise Result or Readings	554	564
Non Reproducible Results	322	322
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	58	58
Device Difficult to Setup or Prepare	51	51
No Device Output	37	37
Lack of Maintenance Documentation or Guidelines	16	16
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
Device Contamination with Chemical or Other Material	3	3
Insufficient Information	3	3
Shipping Damage or Problem	2	2
Unable to Obtain Readings	2	2
Contamination	2	2
Audible Prompt/Feedback Problem	2	2
Failure to Transmit Record	2	2
Device Sensing 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
Therapeutic or Diagnostic Output Failure	1	1
Material Twisted/Bent	1	2
Material Discolored	1	1
Component Missing	1	1
Material Integrity Problem	1	1
Environmental Compatibility Problem	1	1
Defective Component	1	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3251	3261
No Consequences Or Impact To Patient	222	222
Insufficient Information	79	81
Stroke/CVA	25	25
Thrombosis/Thrombus	22	22
Ischemia Stroke	19	19
Transient Ischemic Attack	15	15
Thromboembolism	10	10
Hemorrhage/Bleeding	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Gastrointestinal Hemorrhage	8	8
Hemorrhagic Stroke	8	8
Dizziness	7	7
Coagulation Disorder	7	7
Atrial Fibrillation	7	7
Pulmonary Embolism	6	6
Speech Disorder	6	6
Numbness	4	4
Unspecified Heart Problem	3	3
Balance Problems	3	3
Confusion/ Disorientation	3	3
Urinary Tract Infection	2	2
Cognitive Changes	2	2
Intracranial Hemorrhage	2	2
Ischemia	2	2
Chest Pain	2	2
Hematuria	2	2
Headache	2	2
Cardiac Enzyme Elevation	2	2
Laceration(s)	2	2
Bruise/Contusion	1	1
Abdominal Pain	1	1
Quadriplegia	1	1
Low Blood Pressure/ Hypotension	1	1
Patient Problem/Medical Problem	1	1
Loss of Vision	1	1
Fainting	1	1
Pulmonary Hypertension	1	1
Melena	1	1
Wound Dehiscence	1	1
Blurred Vision	1	1
Phlebitis	1	1
Myocardial Infarction	1	1
Arrhythmia	1	1
Cough	1	1
Unspecified Kidney or Urinary Problem	1	1
Valvular Stenosis	1	1
Visual Impairment	1	1
Pain	1	1
Fall	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