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
ORTHO-CLINICAL DIAGNOSTICS, 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)

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	3151	3160
Non Reproducible Results	849	862
False Positive Result	465	465
Low Test Results	245	251
Incorrect, Inadequate or Imprecise Result or Readings	166	166
Incorrect Measurement	77	80
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
Manufacturing, Packaging or Shipping Problem	3	3
Mechanical Problem	3	4
Product Quality Problem	2	2
Contamination of Device Ingredient or Reagent	2	2
Device Difficult to Maintain	2	2
Imprecision	2	2
Compatibility Problem	2	2
Imprecise or Erratic Results	2	2
Contamination /Decontamination Problem	2	2
Failure to Calibrate	2	2
Use of Device Problem	2	2
No Device Output	1	1
Contamination	1	1
Device Damaged Prior to Use	1	1
Device Displays Incorrect Message	1	1
Calibration Problem	1	1
Device Ingredient or Reagent Problem	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3363	3380
No Known Impact Or Consequence To Patient	203	203
Chest Pain	150	150
Insufficient Information	112	112
No Consequences Or Impact To Patient	91	91
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	43	43
High Blood Pressure/ Hypertension	26	26
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
Dyspnea	10	10
Nausea	10	10
Tachycardia	8	8
Heart Failure/Congestive Heart Failure	8	8
Headache	7	7
Anxiety	7	7
Fatigue	7	7
Syncope/Fainting	6	6
Vomiting	6	6
Back pain	5	5
Dehydration	5	5
Unspecified Respiratory Problem	5	5
Fever	5	5
Cough	5	5
Respiratory Insufficiency	5	5
Atrial Fibrillation	5	5
Respiratory Failure	5	5
No Information	5	5
Respiratory Distress	4	4
Hernia	4	4
Muscle Weakness/Atrophy	4	4
Fall	4	4
Limb Pain	4	4
Pneumonia	4	4
Chronic Obstructive Pulmonary Disease (COPD)	4	4
Diarrhea	4	4
Vertigo	3	3
Swelling/ Edema	3	3
Palpitations	3	3
Heartburn/Indigestion	3	3
Myocarditis	3	3
Patient Problem/Medical Problem	3	3
Adult Respiratory Distress Syndrome	3	3
Asthma	3	3
Ischemic Heart Disease	3	3
Unspecified Heart Problem	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