TPLC - Total Product Life Cycle

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Device	immunoassay method, troponin subunit
Product Code	MMI
Regulation Number	862.1215
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES DIAGNOSTICS DIVISION
	SUBSTANTIALLY EQUIVALENT	3
BECKMAN COULTER INC
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K241165 Atellica® IM High-Sensitivity Troponin I (TnIH)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	2334	2334
Non Reproducible Results	492	492
False Positive Result	454	454
Low Test Results	180	180
Incorrect, Inadequate or Imprecise Result or Readings	114	114
No Apparent Adverse Event	72	72
False Negative Result	60	60
Incorrect Measurement	51	51
High Readings	35	35
Adverse Event Without Identified Device or Use Problem	22	22
Output Problem	13	13
Low Readings	9	9
Mechanical Problem	5	5
Insufficient Information	5	5
Appropriate Term/Code Not Available	4	4
Material Integrity Problem	4	4
Unexpected Therapeutic Results	4	4
Contamination of Device Ingredient or Reagent	4	4
Unable to Obtain Readings	4	4
Use of Device Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Compatibility Problem	2	2
Device Difficult to Maintain	2	2
Product Quality Problem	2	2
Nonstandard Device	2	2
No Device Output	1	1
Contamination	1	1
Device Displays Incorrect Message	1	1
Patient-Device Incompatibility	1	1
Chemical Problem	1	1
Contamination /Decontamination Problem	1	1
Device Ingredient or Reagent Problem	1	1
Erratic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2150	2150
No Known Impact Or Consequence To Patient	399	399
No Consequences Or Impact To Patient	269	269
Chest Pain	126	126
Insufficient Information	61	61
No Code Available	59	59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	40
No Information	36	36
Dizziness	23	23
High Blood Pressure/ Hypertension	22	22
Pain	18	18
Myocardial Infarction	16	16
Abdominal Pain	12	12
Respiratory Distress	10	10
Vomiting	9	9
Cardiac Enzyme Elevation	8	8
Nausea	7	7
Decreased Respiratory Rate	6	6
Fall	6	6
Headache	6	6
Heart Failure/Congestive Heart Failure	6	6
Chronic Obstructive Pulmonary Disease (COPD)	5	5
Dyspnea	5	5
Unspecified Respiratory Problem	5	5
Anxiety	5	5
Congestive Heart Failure	5	5
Weakness	4	4
Dehydration	4	4
Asthma	4	4
Ischemic Heart Disease	4	4
Respiratory Failure	4	4
Syncope/Fainting	4	4
Misdiagnosis	3	3
Pneumonia	3	3
Fatigue	3	3
Adult Respiratory Distress Syndrome	3	3
Sore Throat	3	3
Respiratory Insufficiency	3	3
Liver Damage/Dysfunction	3	3
Diarrhea	3	3
Myocarditis	3	3
Patient Problem/Medical Problem	3	3
Tachycardia	2	2
Cough	2	2
Hypoxia	2	2
Hyperglycemia	2	2
Cancer	2	2
Vertigo	2	2
Pulmonary Embolism	2	2
Neck Pain	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	II	Aug-30-2022
2	Abbott Point Of Care Inc.	II	Dec-31-2019
3	Beckman Coulter Inc.	II	Oct-06-2021
4	ORTHO-CLINICAL DIAGNOSTICS	II	Aug-08-2023
5	QUIDEL CARDIOVASCULAR INC	I	Jul-07-2023
6	Roche Diagnostics Operations, Inc.	II	May-14-2021
7	Siemens Healthcare Diagnostics Inc	II	Jul-30-2019
8	Siemens Healthcare Diagnostics, Inc.	II	Jul-06-2022
9	Siemens Healthcare Diagnostics, Inc.	II	Oct-02-2020
10	Siemens Healthcare Diagnostics, Inc.	II	Sep-02-2020