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	4
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	2874	2874
Incorrect, Inadequate or Imprecise Result or Readings	798	811
Non Reproducible Results	443	443
Low Test Results	392	392
Image Display Error/Artifact	239	239
Display Difficult to Read	178	178
Circuit Failure	95	95
Incorrect Measurement	75	75
Adverse Event Without Identified Device or Use Problem	56	56
Device Difficult to Setup or Prepare	51	51
No Device Output	39	39
High Readings	19	19
Display or Visual Feedback Problem	18	19
Lack of Maintenance Documentation or Guidelines	16	16
Output Problem	11	11
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	5
Battery Problem	4	4
Use of Device Problem	4	4
Unexpected Therapeutic Results	4	4
Erratic or Intermittent Display	4	4
Insufficient Information	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Device Displays Incorrect Message	3	6
Loss of Data	3	3
Human-Device Interface Problem	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
Shipping Damage or Problem	2	2
Mechanical Problem	2	2
Audible Prompt/Feedback Problem	2	2
No Display/Image	2	2
Computer Software Problem	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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3243	3253
No Consequences Or Impact To Patient	1533	1533
Insufficient Information	80	82
No Known Impact Or Consequence To Patient	31	34
Stroke/CVA	26	26
Coagulation Disorder	24	24
Thrombosis/Thrombus	23	23
Ischemia Stroke	19	19
Transient Ischemic Attack	15	15
Thromboembolism	10	10
Hemorrhage/Bleeding	10	10
Pulmonary Embolism	9	9
Atrial Fibrillation	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Gastrointestinal Hemorrhage	8	8
Hemorrhagic Stroke	8	8
Dizziness	7	7
Speech Disorder	6	6
No Information	5	5
Numbness	4	4
Unspecified Heart Problem	3	3
Balance Problems	3	3
Ischemia	3	3
No Patient Involvement	3	3
Confusion/ Disorientation	3	3
Urinary Tract Infection	2	2
Thrombus	2	2
Headache	2	2
Cardiac Enzyme Elevation	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
Fainting	1	1
Wound Dehiscence	1	1
Arrhythmia	1	1
Nausea	1	1
Respiratory Distress	1	1
Sepsis	1	1
Blurred Vision	1	1
Phlebitis	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