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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 1
PHC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 521 521
2020 387 387
2021 356 356
2022 507 507
2023 756 756
2024 480 480

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 2128 2128
Non Reproducible Results 412 412
False Positive Result 409 409
Low Test Results 158 158
Incorrect, Inadequate or Imprecise Result or Readings 108 108
No Apparent Adverse Event 71 71
False Negative Result 59 59
Incorrect Measurement 42 42
High Readings 35 35
Adverse Event Without Identified Device or Use Problem 22 22
Output Problem 10 10
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
Mechanical Problem 3 3
Appropriate Term/Code Not Available 3 3
Unable to Obtain Readings 3 3
Material Integrity Problem 3 3
Device Difficult to Maintain 2 2
Nonstandard Device 2 2
Compatibility Problem 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Displays Incorrect Message 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
No Device Output 1 1
Product Quality Problem 1 1
Contamination 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1895 1895
No Known Impact Or Consequence To Patient 399 399
No Consequences Or Impact To Patient 269 269
Chest Pain 114 114
No Code Available 59 59
Insufficient Information 53 53
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
No Information 36 36
Dizziness 20 20
High Blood Pressure/ Hypertension 19 19
Pain 18 18
Myocardial Infarction 14 14
Abdominal Pain 12 12
Respiratory Distress 10 10
Vomiting 9 9
Cardiac Enzyme Elevation 7 7
Fall 6 6
Headache 6 6
Nausea 6 6
Dyspnea 5 5
Congestive Heart Failure 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Heart Failure/Congestive Heart Failure 5 5
Decreased Respiratory Rate 5 5
Unspecified Respiratory Problem 5 5
Respiratory Failure 4 4
Anxiety 4 4
Weakness 4 4
Asthma 4 4
Adult Respiratory Distress Syndrome 3 3
Dehydration 3 3
Diarrhea 3 3
Liver Damage/Dysfunction 3 3
Misdiagnosis 3 3
Pneumonia 3 3
Sore Throat 3 3
Myocarditis 3 3
Ischemic Heart Disease 3 3
Patient Problem/Medical Problem 3 3
Syncope/Fainting 3 3
Respiratory Insufficiency 3 3
Cancer 2 2
Cough 2 2
Test Result 2 2
Neck Pain 2 2
Chest Tightness/Pressure 2 2
Palpitations 2 2
Hyperglycemia 2 2
Diabetic Ketoacidosis 2 2
Sepsis 2 2
Tachycardia 2 2
Vertigo 2 2
Hypoxia 2 2
Pyrosis/Heartburn 2 2
Fatigue 2 2
Fever 2 2
Bone Fracture(s) 2 2
Bruise/Contusion 2 2
Cardiac Arrest 2 2
Stroke/CVA 2 2
Pulmonary Embolism 2 2
Syncope 1 1
Atrial Fibrillation 1 1
Apnea 1 1
Arrhythmia 1 1
Arthritis 1 1
Breast Cancer 1 1
Intracranial Hemorrhage 1 1
Encephalopathy 1 1
Itching Sensation 1 1
Hyperventilation 1 1
Low Blood Pressure/ Hypotension 1 1
Memory Loss/Impairment 1 1
Blurred Vision 1 1
Visual Impairment 1 1
HIV, Human Immunodeficiency Virus 1 1
Chills 1 1
Transient Ischemic Attack 1 1
Urinary Tract Infection 1 1
Ventricular Tachycardia 1 1
Pneumothorax 1 1
ST Segment Elevation 1 1
Seizures 1 1
Injury 1 1
Hernia 1 1
Heart Failure 1 1
Irregular Pulse 1 1
Diaphoresis 1 1
Perforation of Esophagus 1 1
Numbness 1 1
Loss of consciousness 1 1
Respiratory Tract Infection 1 1
Confusion/ Disorientation 1 1
Lethargy 1 1
Pulmonary Hypertension 1 1
Unspecified Heart Problem 1 1
Gastroesophageal Burn 1 1
Limb Fracture 1 1
Skin Disorders 1 1
Swelling/ Edema 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 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
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