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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 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
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