TPLC - Total Product Life Cycle

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Device	immunoassay method, troponin subunit
Product Code	MMI
Regulation Number	862.1215
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES DIAGNOSTICS DIVISION
	SUBSTANTIALLY EQUIVALENT	3
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
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	2296	2296
Non Reproducible Results	478	478
False Positive Result	452	452
Low Test Results	174	174
Incorrect, Inadequate or Imprecise Result or Readings	114	114
No Apparent Adverse Event	72	72
False Negative Result	60	60
Incorrect Measurement	50	50
High Readings	35	35
Adverse Event Without Identified Device or Use Problem	22	22
Output Problem	11	11
Low Readings	9	9
Insufficient Information	5	5
Mechanical Problem	4	4
Material Integrity Problem	4	4
Unable to Obtain Readings	4	4
Contamination of Device Ingredient or Reagent	4	4
Appropriate Term/Code Not Available	4	4
Unexpected Therapeutic Results	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Use of Device Problem	3	3
Compatibility Problem	2	2
Device Difficult to Maintain	2	2
Product Quality Problem	2	2
Nonstandard Device	2	2
Device Ingredient or Reagent Problem	1	1
Patient-Device Incompatibility	1	1
Erratic Results	1	1
Contamination	1	1
Contamination /Decontamination Problem	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	2109	2109
No Known Impact Or Consequence To Patient	399	399
No Consequences Or Impact To Patient	269	269
Chest Pain	122	122
No Code Available	59	59
Insufficient Information	58	58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	40
No Information	36	36
Dizziness	23	23
High Blood Pressure/ Hypertension	20	20
Pain	18	18
Myocardial Infarction	15	15
Abdominal Pain	12	12
Respiratory Distress	10	10
Vomiting	9	9
Cardiac Enzyme Elevation	8	8
Nausea	7	7
Decreased Respiratory Rate	6	6
Fall	6	6
Headache	6	6
Heart Failure/Congestive Heart Failure	6	6
Chronic Obstructive Pulmonary Disease (COPD)	5	5
Dyspnea	5	5
Unspecified Respiratory Problem	5	5
Anxiety	5	5
Congestive Heart Failure	5	5
Weakness	4	4
Dehydration	4	4
Asthma	4	4
Ischemic Heart Disease	4	4
Respiratory Failure	4	4
Syncope/Fainting	4	4
Misdiagnosis	3	3
Pneumonia	3	3
Fatigue	3	3
Adult Respiratory Distress Syndrome	3	3
Sore Throat	3	3
Respiratory Insufficiency	3	3
Liver Damage/Dysfunction	3	3
Diarrhea	3	3
Myocarditis	3	3
Patient Problem/Medical Problem	3	3
Tachycardia	2	2
Cough	2	2
Hypoxia	2	2
Hyperglycemia	2	2
Cancer	2	2
Vertigo	2	2
Pulmonary Embolism	2	2
Neck Pain	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	II	Aug-30-2022
2	Abbott Point Of Care Inc.	II	Dec-31-2019
3	Beckman Coulter Inc.	II	Oct-06-2021
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-30-2019
8	Siemens Healthcare Diagnostics, Inc.	II	Jul-06-2022
9	Siemens Healthcare Diagnostics, Inc.	II	Oct-02-2020
10	Siemens Healthcare Diagnostics, Inc.	II	Sep-02-2020