Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
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
2
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
2
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
487
487
2019
521
521
2020
387
387
2021
356
356
2022
507
507
2023
81
81
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
1407
1407
False Positive Result
441
441
Non Reproducible Results
137
137
No Apparent Adverse Event
108
108
Low Test Results
107
107
False Negative Result
72
72
Adverse Event Without Identified Device or Use Problem
68
68
Incorrect, Inadequate or Imprecise Result or Readings
60
60
High Readings
39
39
Incorrect Or Inadequate Test Results
20
20
Incorrect Measurement
20
20
Low Readings
6
6
Insufficient Information
5
5
Contamination of Device Ingredient or Reagent
4
4
Unexpected Therapeutic Results
4
4
Use of Device Problem
3
3
Device Operates Differently Than Expected
3
3
Appropriate Term/Code Not Available
2
2
Electrical /Electronic Property Problem
2
2
Nonstandard Device
2
2
Unable to Obtain Readings
2
2
Device Ingredient or Reagent Problem
1
1
Patient-Device Incompatibility
1
1
No Device Output
1
1
Product Quality Problem
1
1
Output Problem
1
1
Erratic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
828
828
No Known Impact Or Consequence To Patient
646
646
No Consequences Or Impact To Patient
366
366
Chest Pain
109
109
No Code Available
98
98
No Information
72
72
Insufficient Information
46
46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
32
32
Pain
20
20
Dizziness
19
19
Respiratory Distress
18
18
High Blood Pressure/ Hypertension
16
16
Abdominal Pain
9
9
Vomiting
9
9
Chest Tightness/Pressure
8
8
Weakness
6
6
Myocardial Infarction
6
6
Chronic Obstructive Pulmonary Disease (COPD)
6
6
Congestive Heart Failure
6
6
Headache
6
6
Fall
6
6
Dyspnea
5
5
Cardiac Enzyme Elevation
5
5
Nausea
5
5
Test Result
5
5
Respiratory Failure
4
4
Decreased Respiratory Rate
4
4
Pneumonia
4
4
Misdiagnosis
4
4
Anxiety
4
4
Asthma
4
4
Diarrhea
3
3
Stroke/CVA
3
3
Fever
3
3
Liver Damage/Dysfunction
3
3
Discomfort
3
3
Tachycardia
3
3
Transient Ischemic Attack
3
3
Palpitations
3
3
No Patient Involvement
3
3
Patient Problem/Medical Problem
3
3
Unspecified Respiratory Problem
3
3
Cancer
2
2
Cough
2
2
Neck Pain
2
2
Hyperglycemia
2
2
Irregular Pulse
2
2
Myocarditis
2
2
Ischemic Heart Disease
2
2
Confusion/ Disorientation
2
2
Urinary Tract Infection
2
2
Diabetic Ketoacidosis
2
2
Numbness
2
2
Vertigo
2
2
Blurred Vision
2
2
Hypoxia
2
2
Bone Fracture(s)
2
2
Fatigue
2
2
Bruise/Contusion
2
2
Atrial Fibrillation
2
2
Pulmonary Embolism
2
2
Syncope
2
2
Atrial Flutter
1
1
Adult Respiratory Distress Syndrome
1
1
Anemia
1
1
Apnea
1
1
Arthritis
1
1
Breast Cancer
1
1
Cardiac Arrest
1
1
Cellulitis
1
1
Dysphagia/ Odynophagia
1
1
Dehydration
1
1
Ecchymosis
1
1
Itching Sensation
1
1
Memory Loss/Impairment
1
1
Muscle Spasm(s)
1
1
Pyrosis/Heartburn
1
1
Hyperventilation
1
1
Hypoventilation
1
1
Visual Impairment
1
1
HIV, Human Immunodeficiency Virus
1
1
Hernia
1
1
Heart Failure
1
1
Loss of consciousness
1
1
Respiratory Tract Infection
1
1
Sore Throat
1
1
Perforation of Esophagus
1
1
Injury
1
1
Depression
1
1
Ventricular Tachycardia
1
1
Thyroid Problems
1
1
Tingling
1
1
Chills
1
1
Rash
1
1
Overdose
1
1
ST Segment Elevation
1
1
Seizures
1
1
Sepsis
1
1
Electric Shock
1
1
Lethargy
1
1
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
Roche Diagnostics Operations, Inc.
II
May-14-2021
5
Siemens Healthcare Diagnostics Inc
II
Jul-30-2019
6
Siemens Healthcare Diagnostics, Inc.
II
Jul-06-2022
7
Siemens Healthcare Diagnostics, Inc.
II
Oct-02-2020
8
Siemens Healthcare Diagnostics, Inc.
II
Sep-02-2020
9
Siemens Healthcare Diagnostics, Inc.
II
Jul-13-2018
10
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
11
Tosoh Bioscience Inc
II
Jun-05-2018
-
-