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	2
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	4
1. K222881 Access hsTnI
2. K230648 Access hsTnI
3. K242870 Access hsTnI
4. K243483 Access hsTnI
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	3199	3208
Non Reproducible Results	859	872
False Positive Result	478	478
Low Test Results	252	258
Incorrect, Inadequate or Imprecise Result or Readings	169	169
Incorrect Measurement	81	84
False Negative Result	43	43
No Apparent Adverse Event	41	42
Output Problem	39	39
High Readings	15	15
Low Readings	12	12
Unable to Obtain Readings	10	10
Insufficient Device Problem Information	9	9
Appropriate Device Problem Term/Code Not Available	6	6
Material Integrity Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Signal Artifact/Noise	4	4
Mechanical Problem	3	4
Manufacturing, Packaging or Shipping Problem	3	3
Contamination /Decontamination Problem	3	3
Compatibility Problem	2	2
Imprecision	2	2
Use of Device Problem	2	2
Device Difficult to Maintain	2	2
Imprecise or Erratic Results	2	2
Product Quality Problem	2	2
Contamination of Device Ingredient or Reagent	2	2
Failure to Calibrate	2	2
Device Ingredient or Reagent Problem	1	1
Device Damaged Prior to Use	1	1
Contamination	1	1
Calibration Problem	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	3418	3435
No Known Impact Or Consequence To Patient	203	203
Chest Pain	153	153
Insufficient Information	114	114
No Consequences Or Impact To Patient	91	91
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	43	43
High Blood Pressure/ Hypertension	27	27
Dizziness	23	23
No Code Available	21	21
Myocardial Infarction	20	20
Decreased Respiratory Rate	20	20
Pain	19	19
Cardiac Enzyme Elevation	19	19
Abdominal Pain	19	19
Nausea	10	10
Tachycardia	10	10
Dyspnea	10	10
Syncope/Fainting	8	8
Anxiety	8	8
Heart Failure/Congestive Heart Failure	8	8
Headache	7	7
Fatigue	7	7
Limb Pain	7	7
Vomiting	6	6
Atrial Fibrillation	6	6
Pneumonia	6	6
Respiratory Insufficiency	5	5
Chronic Obstructive Pulmonary Disease (COPD)	5	5
Respiratory Failure	5	5
Unspecified Respiratory Problem	5	5
Fever	5	5
Cough	5	5
No Information	5	5
Back pain	5	5
Dehydration	5	5
Diarrhea	4	4
Respiratory Distress	4	4
Muscle Weakness/Atrophy	4	4
Hernia	4	4
Fall	4	4
Myocarditis	3	3
Palpitations	3	3
Vertigo	3	3
Asthma	3	3
Ischemic Heart Disease	3	3
Swelling/ Edema	3	3
Adult Respiratory Distress Syndrome	3	3
Patient Problem/Medical Problem	3	3
Heartburn/Indigestion	3	3
Hyperglycemia	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