TPLC - Total Product Life Cycle

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Device	immunoassay method, troponin subunit
Regulation Description	Creatine phosphokinase/creatine kinase or isoenzymes test system.
Product Code	MMI
Regulation Number	862.1215
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES DIAGNOSTICS DIVISION
	SUBSTANTIALLY EQUIVALENT	2
ABBOTT POINT OF CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	4
ORTHO-CLINICAL DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	2751	2760
Non Reproducible Results	762	775
False Positive Result	371	371
Low Test Results	203	209
Incorrect, Inadequate or Imprecise Result or Readings	131	131
Incorrect Measurement	63	66
Output Problem	33	33
False Negative Result	28	28
High Readings	15	15
No Apparent Adverse Event	11	12
Low Readings	10	10
Insufficient Information	9	9
Unable to Obtain Readings	8	8
Material Integrity Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Appropriate Term/Code Not Available	5	5
Signal Artifact/Noise	4	4
Contamination of Device Ingredient or Reagent	4	4
Mechanical Problem	3	4
Manufacturing, Packaging or Shipping Problem	3	3
Use of Device Problem	3	3
Compatibility Problem	2	2
Contamination /Decontamination Problem	2	2
Device Difficult to Maintain	2	2
Product Quality Problem	2	2
Failure to Calibrate	2	2
Device Ingredient or Reagent Problem	1	1
Device Damaged Prior to Use	1	1
Erratic Results	1	1
Defective Device	1	1
Contamination	1	1
Imprecision	1	1
Protective Measures Problem	1	1
Nonstandard Device	1	1
Device Displays Incorrect Message	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3057	3074
Chest Pain	120	120
Insufficient Information	105	105
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	42	42
Dizziness	20	20
High Blood Pressure/ Hypertension	19	19
Cardiac Enzyme Elevation	19	19
Myocardial Infarction	19	19
Decreased Respiratory Rate	17	17
Abdominal Pain	12	12
Dyspnea	10	10
Pain	10	10
No Known Impact Or Consequence To Patient	10	10
Nausea	8	8
Heart Failure/Congestive Heart Failure	8	8
Syncope/Fainting	6	6
Headache	6	6
Respiratory Failure	5	5
Respiratory Insufficiency	5	5
No Consequences Or Impact To Patient	5	5
Unspecified Respiratory Problem	5	5
Tachycardia	5	5
Anxiety	5	5
Dehydration	5	5
Atrial Fibrillation	5	5
Fatigue	5	5
Muscle Weakness	4	4
Cough	4	4
Vomiting	4	4
Fever	4	4
Pneumonia	3	3
Fall	3	3
Swelling/ Edema	3	3
Adult Respiratory Distress Syndrome	3	3
Pyrosis/Heartburn	3	3
Ischemic Heart Disease	3	3
Asthma	3	3
Chronic Obstructive Pulmonary Disease (COPD)	3	3
Myocarditis	3	3
Hernia	2	2
Diarrhea	2	2
Vertigo	2	2
Diabetic Ketoacidosis	2	2
Unspecified Heart Problem	2	2
Neck Pain	2	2
Stroke/CVA	2	2
Cardiac Arrest	2	2
Bone Fracture(s)	2	2
Sore Throat	2	2
Bruise/Contusion	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	II	Aug-30-2022
2	Beckman Coulter Inc.	II	Oct-06-2021
3	Beckman Coulter, Inc.	II	Dec-20-2024
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-06-2022