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
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	2528	2528
Non Reproducible Results	617	617
False Positive Result	324	324
Low Test Results	182	182
Incorrect, Inadequate or Imprecise Result or Readings	124	124
Incorrect Measurement	59	59
No Apparent Adverse Event	41	41
False Negative Result	37	37
High Readings	21	21
Output Problem	17	17
Unable to Obtain Readings	7	7
Low Readings	6	6
Material Integrity Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Insufficient Information	5	5
Appropriate Term/Code Not Available	5	5
Mechanical Problem	4	4
Contamination of Device Ingredient or Reagent	4	4
Signal Artifact/Noise	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Use of Device Problem	3	3
Device Difficult to Maintain	2	2
Product Quality Problem	2	2
Compatibility Problem	2	2
Contamination	1	1
Erratic Results	1	1
Imprecision	1	1
Nonstandard Device	1	1
No Device Output	1	1
Unexpected Therapeutic Results	1	1
Device Damaged Prior to Use	1	1
Failure to Calibrate	1	1
Device Displays Incorrect Message	1	1
Contamination /Decontamination Problem	1	1
Device Ingredient or Reagent Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2592	2592
No Known Impact Or Consequence To Patient	203	203
Chest Pain	101	101
No Consequences Or Impact To Patient	91	91
Insufficient Information	81	81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	40
No Code Available	21	21
Dizziness	18	18
Myocardial Infarction	16	16
High Blood Pressure/ Hypertension	15	15
Abdominal Pain	10	10
Pain	10	10
Dyspnea	9	9
Decreased Respiratory Rate	8	8
Cardiac Enzyme Elevation	8	8
Nausea	7	7
Heart Failure/Congestive Heart Failure	6	6
Unspecified Respiratory Problem	5	5
Syncope/Fainting	5	5
No Information	5	5
Vomiting	4	4
Respiratory Distress	4	4
Pneumonia	4	4
Respiratory Insufficiency	4	4
Cough	4	4
Headache	4	4
Dehydration	4	4
Fall	4	4
Ischemic Heart Disease	3	3
Adult Respiratory Distress Syndrome	3	3
Respiratory Failure	3	3
Myocarditis	3	3
Patient Problem/Medical Problem	3	3
Pyrosis/Heartburn	3	3
Diarrhea	3	3
Fever	3	3
Anxiety	3	3
Fatigue	3	3
Atrial Fibrillation	3	3
Asthma	3	3
Misdiagnosis	2	2
Cardiac Arrest	2	2
Bruise/Contusion	2	2
Vertigo	2	2
Tachycardia	2	2
Stroke/CVA	2	2
Congestive Heart Failure	2	2
Muscle Weakness	2	2
Chronic Obstructive Pulmonary Disease (COPD)	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
8	Siemens Healthcare Diagnostics, Inc.	II	Oct-02-2020
9	Siemens Healthcare Diagnostics, Inc.	II	Sep-02-2020