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	2915	2924
Non Reproducible Results	819	832
False Positive Result	407	407
Low Test Results	225	231
Incorrect, Inadequate or Imprecise Result or Readings	153	153
Incorrect Measurement	67	70
Output Problem	39	39
False Negative Result	31	31
High Readings	15	15
Low Readings	12	12
No Apparent Adverse Event	11	12
Unable to Obtain Readings	10	10
Insufficient Information	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
Imprecision	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
Calibration Problem	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	3255	3272
Chest Pain	131	131
Insufficient Information	108	108
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	42	42
High Blood Pressure/ Hypertension	24	24
Dizziness	21	21
Decreased Respiratory Rate	20	20
Myocardial Infarction	20	20
Cardiac Enzyme Elevation	19	19
Pain	17	17
Abdominal Pain	15	15
No Known Impact Or Consequence To Patient	10	10
Dyspnea	10	10
Nausea	9	9
Tachycardia	8	8
Heart Failure/Congestive Heart Failure	8	8
Fatigue	7	7
Headache	7	7
Anxiety	7	7
Syncope/Fainting	6	6
Unspecified Respiratory Problem	5	5
No Consequences Or Impact To Patient	5	5
Respiratory Insufficiency	5	5
Dehydration	5	5
Respiratory Failure	5	5
Atrial Fibrillation	5	5
Vomiting	5	5
Fever	5	5
Cough	4	4
Muscle Weakness	4	4
Hernia	4	4
Chronic Obstructive Pulmonary Disease (COPD)	4	4
Adult Respiratory Distress Syndrome	3	3
Swelling/ Edema	3	3
Ischemic Heart Disease	3	3
Pneumonia	3	3
Fall	3	3
Asthma	3	3
Pyrosis/Heartburn	3	3
Vertigo	3	3
Diarrhea	3	3
Myocarditis	3	3
Unspecified Heart Problem	2	2
Sore Throat	2	2
Loss of consciousness	2	2
Bruise/Contusion	2	2
Neck Pain	2	2
Confusion/ Disorientation	2	2
Palpitations	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