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
1. K231974 PATHFAST®hs-cTnI-II
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	2792	2801
Non Reproducible Results	776	789
False Positive Result	379	379
Low Test Results	212	218
Incorrect, Inadequate or Imprecise Result or Readings	139	139
Incorrect Measurement	65	68
Output Problem	35	35
False Negative Result	31	31
High Readings	15	15
No Apparent Adverse Event	11	12
Low Readings	10	10
Insufficient Information	9	9
Unable to Obtain Readings	9	9
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	3113	3130
Chest Pain	120	120
Insufficient Information	106	106
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	42	42
High Blood Pressure/ Hypertension	21	21
Dizziness	20	20
Cardiac Enzyme Elevation	19	19
Myocardial Infarction	19	19
Decreased Respiratory Rate	17	17
Abdominal Pain	13	13
Pain	11	11
Dyspnea	10	10
No Known Impact Or Consequence To Patient	10	10
Nausea	8	8
Heart Failure/Congestive Heart Failure	8	8
Tachycardia	7	7
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
Fatigue	5	5
Anxiety	5	5
Dehydration	5	5
Atrial Fibrillation	5	5
Cough	4	4
Muscle Weakness	4	4
Vomiting	4	4
Fever	4	4
Chronic Obstructive Pulmonary Disease (COPD)	4	4
Swelling/ Edema	3	3
Pneumonia	3	3
Fall	3	3
Vertigo	3	3
Diarrhea	3	3
Myocarditis	3	3
Pyrosis/Heartburn	3	3
Asthma	3	3
Ischemic Heart Disease	3	3
Adult Respiratory Distress Syndrome	3	3
Cardiac Arrest	2	2
Bruise/Contusion	2	2
Anemia	2	2
Neck Pain	2	2
Sore Throat	2	2
Stroke/CVA	2	2
Hernia	2	2
Unspecified Heart Problem	2	2
Bone Fracture(s)	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