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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoassay method, troponin subunit
Product CodeMMI
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 3
BECKMAN COULTER INC
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 5
MITSUBISHI CHEMICAL MEDIENCE CO
  SUBSTANTIALLY EQUIVALENT 1
NANO-DITECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PHC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1150 1150
2015 831 831
2016 487 487
2017 618 618
2018 487 487
2019 521 521
2020 387 387
2021 356 356
2022 507 507
2023 756 756
2024 402 402

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 4035 4035
False Positive Result 898 898
Incorrect Or Inadequate Test Results 405 405
Non Reproducible Results 400 400
Incorrect, Inadequate or Imprecise Result or Readings 361 361
Low Test Results 286 286
False Negative Result 227 227
Adverse Event Without Identified Device or Use Problem 161 161
No Apparent Adverse Event 108 108
High Readings 48 48
Incorrect Measurement 43 43
Nonstandard Device 34 34
Device Operates Differently Than Expected 16 16
Device Displays Incorrect Message 13 13
False Reading From Device Non-Compliance 12 12
Insufficient Information 11 11
Air Leak 10 10
Product Quality Problem 10 10
Low Readings 8 8
False Device Output 8 8
Output Problem 8 8
Failure to Obtain Sample 7 7
Defective Component 7 7
Unexpected Therapeutic Results 6 6
Failure to Calibrate 6 6
Calibration Problem 6 6
Use of Device Problem 5 5
Unable to Obtain Readings 4 4
Loose or Intermittent Connection 4 4
Contamination of Device Ingredient or Reagent 4 4
Appropriate Term/Code Not Available 4 4
Material Integrity Problem 3 3
Mechanical Problem 3 3
Electrical /Electronic Property Problem 2 2
Imprecision 2 2
Contamination 2 2
Calibration Error 2 2
Improper or Incorrect Procedure or Method 2 2
Device Difficult to Maintain 2 2
Device Ingredient or Reagent Problem 2 2
Compatibility Problem 2 2
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Application Program Problem: Medication Error 1 1
Device Handling Problem 1 1
Device Contamination With Biological Material 1 1
Contamination /Decontamination Problem 1 1
Device Sensing Problem 1 1
Fail-Safe Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Improper Device Output 1 1
Erratic Results 1 1
Microbial Contamination of Device 1 1
Patient-Device Incompatibility 1 1
Difficult or Delayed Activation 1 1
Device Reprocessing Problem 1 1
Clumping in Device or Device Ingredient 1 1
False Alarm 1 1
Bent 1 1
Use of Incorrect Control/Treatment Settings 1 1
Fluid/Blood Leak 1 1
Poor Quality Image 1 1
No Device Output 1 1
Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2465 2465
No Clinical Signs, Symptoms or Conditions 1822 1822
No Consequences Or Impact To Patient 945 945
No Code Available 409 409
Chest Pain 234 234
No Information 213 213
Insufficient Information 53 53
Misdiagnosis 47 47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Pain 36 36
Test Result 31 31
Dizziness 29 29
Respiratory Distress 27 27
Myocardial Infarction 26 26
High Blood Pressure/ Hypertension 22 22
Dyspnea 22 22
Abdominal Pain 18 18
Vomiting 14 14
Weakness 11 11
Chronic Obstructive Pulmonary Disease (COPD) 11 11
Chest Tightness/Pressure 11 11
Congestive Heart Failure 11 11
Nausea 10 10
Fall 9 9
Cardiac Enzyme Elevation 8 8
Headache 8 8
Venipuncture 7 7
Anxiety 6 6
Injury 5 5
Sore Throat 5 5
Transient Ischemic Attack 5 5
No Patient Involvement 5 5
Patient Problem/Medical Problem 5 5
Respiratory Failure 5 5
Decreased Respiratory Rate 5 5
Ischemic Heart Disease 5 5
Heart Failure/Congestive Heart Failure 5 5
Unspecified Respiratory Problem 5 5
Pneumonia 5 5
Tachycardia 5 5
Fatigue 5 5
Fever 5 5
Asthma 5 5
Atrial Fibrillation 4 4
Death 4 4
Syncope 4 4
Stroke/CVA 4 4
Diarrhea 4 4
Renal Failure 4 4
Sepsis 4 4
Hyperglycemia 4 4
Hypoxia 4 4
Vertigo 4 4
Complaint, Ill-Defined 4 4
Discomfort 3 3
Heart Failure 3 3
Palpitations 3 3
Irregular Pulse 3 3
Myocarditis 3 3
Urinary Tract Infection 3 3
Neck Pain 3 3
Liver Damage/Dysfunction 3 3
Overdose 3 3
Bone Fracture(s) 3 3
Cardiac Arrest 3 3
Adult Respiratory Distress Syndrome 3 3
Pulmonary Embolism 2 2
Angina 2 2
Arrhythmia 2 2
Bruise/Contusion 2 2
Seizures 2 2
Hypoglycemia 2 2
Hypoventilation 2 2
Pyrosis/Heartburn 2 2
Hemorrhage/Bleeding 2 2
Confusion/ Disorientation 2 2
Cancer 2 2
Syncope/Fainting 2 2
Cough 2 2
Respiratory Insufficiency 2 2
Ventricular Tachycardia 2 2
Blurred Vision 2 2
Numbness 2 2
Diabetic Ketoacidosis 2 2
Depression 1 1
Loss of consciousness 1 1
Respiratory Tract Infection 1 1
Perforation of Esophagus 1 1
Visual Impairment 1 1
Hernia 1 1
Cardiogenic Shock 1 1
Stenosis 1 1
Ulcer 1 1
HIV, Human Immunodeficiency Virus 1 1
Tingling 1 1
Chills 1 1
Pulmonary Hypertension 1 1
Unspecified Heart Problem 1 1
Gastroesophageal Burn 1 1
Limb Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Aug-30-2022
2 Abbott Laboratories II May-10-2012
3 Abbott Laboratories II Apr-15-2009
4 Abbott Point Of Care Inc. II Dec-31-2019
5 Abbott Point Of Care Inc. II Aug-22-2012
6 Abbott Point Of Care Inc. II Aug-09-2012
7 Abbott Point Of Care Inc. II Nov-10-2011
8 Abbott Point of Care Canada Limited II Jan-24-2013
9 Alere San Diego II Apr-26-2012
10 Beckman Coulter Inc. II Oct-06-2021
11 Beckman Coulter Inc. II Apr-04-2011
12 Beckman Coulter Inc. II Jul-12-2010
13 Beckman Coulter Inc. II Apr-12-2010
14 Biosite Inc I May-08-2009
15 ORTHO-CLINICAL DIAGNOSTICS II Aug-08-2023
16 QUIDEL CARDIOVASCULAR INC I Jul-07-2023
17 Roche Diagnostics Operations, Inc. II May-14-2021
18 Roche Diagnostics Operations, Inc. I Apr-11-2012
19 Siemens Healthcare Diagnostics Inc II Jul-30-2019
20 Siemens Healthcare Diagnostics Inc II Jan-07-2016
21 Siemens Healthcare Diagnostics, Inc II Jun-21-2016
22 Siemens Healthcare Diagnostics, Inc II Jul-23-2015
23 Siemens Healthcare Diagnostics, Inc II Jul-02-2014
24 Siemens Healthcare Diagnostics, Inc. II Jul-06-2022
25 Siemens Healthcare Diagnostics, Inc. II Oct-02-2020
26 Siemens Healthcare Diagnostics, Inc. II Sep-02-2020
27 Siemens Healthcare Diagnostics, Inc. II Jul-13-2018
28 Siemens Healthcare Diagnostics, Inc. II May-04-2018
29 Siemens Healthcare Diagnostics, Inc. II May-05-2017
30 Siemens Healthcare Diagnostics, Inc. II Jun-25-2015
31 Siemens Healthcare Diagnostics, Inc. II Dec-12-2014
32 Siemens Healthcare Diagnostics, Inc. II Mar-18-2011
33 Siemens Healthcare Diagnostics, Inc. II Nov-24-2010
34 Siemens Healthcare Diagnostics, Inc. II Sep-11-2010
35 Siemens Healthcare Diagnostics, Inc. II Feb-25-2010
36 Siemens Healthcare Diagnostics, Inc. II Aug-12-2009
37 Tosoh Bioscience Inc II Jun-05-2018
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