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	1
BECKMAN COULTER INC.
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	2
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	2793	2793
Non Reproducible Results	711	711
False Positive Result	355	355
Low Test Results	187	187
Incorrect, Inadequate or Imprecise Result or Readings	137	137
Incorrect Measurement	64	64
No Apparent Adverse Event	41	41
False Negative Result	37	37
Output Problem	24	24
High Readings	22	22
Low Readings	8	8
Insufficient Information	7	7
Unable to Obtain Readings	7	7
Material Integrity Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Appropriate Term/Code Not Available	5	5
Contamination of Device Ingredient or Reagent	4	4
Signal Artifact/Noise	3	3
Mechanical Problem	3	3
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
Device Ingredient or Reagent Problem	1	1
Pressure Problem	1	1
Device Damaged Prior to Use	1	1
Erratic Results	1	1
Defective Device	1	1
Contamination	1	1
Imprecision	1	1
Failure to Calibrate	1	1
Protective Measures Problem	1	1
Nonstandard Device	1	1
Unexpected Therapeutic Results	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	2853	2853
No Known Impact Or Consequence To Patient	203	203
Chest Pain	111	111
Insufficient Information	99	99
No Consequences Or Impact To Patient	91	91
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	43	43
No Code Available	21	21
Dizziness	21	21
Myocardial Infarction	18	18
Cardiac Enzyme Elevation	17	17
High Blood Pressure/ Hypertension	16	16
Abdominal Pain	11	11
Decreased Respiratory Rate	10	10
Dyspnea	10	10
Pain	10	10
Nausea	8	8
Heart Failure/Congestive Heart Failure	7	7
Syncope/Fainting	5	5
Respiratory Insufficiency	5	5
Headache	5	5
Unspecified Respiratory Problem	5	5
Vomiting	5	5
No Information	5	5
Fever	4	4
Respiratory Failure	4	4
Respiratory Distress	4	4
Cough	4	4
Dehydration	4	4
Pneumonia	4	4
Fall	4	4
Diarrhea	3	3
Myocarditis	3	3
Pyrosis/Heartburn	3	3
Atrial Fibrillation	3	3
Asthma	3	3
Ischemic Heart Disease	3	3
Muscle Weakness	3	3
Tachycardia	3	3
Anxiety	3	3
Fatigue	3	3
Adult Respiratory Distress Syndrome	3	3
Patient Problem/Medical Problem	3	3
Congestive Heart Failure	2	2
Unspecified Heart Problem	2	2
Vertigo	2	2
Sore Throat	2	2
Bruise/Contusion	2	2
Neck Pain	2	2
Chronic Obstructive Pulmonary Disease (COPD)	2	2
Cardiac Arrest	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
8	Siemens Healthcare Diagnostics, Inc.	II	Oct-02-2020
9	Siemens Healthcare Diagnostics, Inc.	II	Sep-02-2020