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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
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 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 1752 1752
False Positive Result 386 386
Non Reproducible Results 355 355
Low Test Results 149 149
Incorrect, Inadequate or Imprecise Result or Readings 91 91
No Apparent Adverse Event 71 71
False Negative Result 58 58
Incorrect Measurement 39 39
High Readings 35 35
Adverse Event Without Identified Device or Use Problem 21 21
Output Problem 5 5
Insufficient Information 5 5
Low Readings 4 4
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
Nonstandard Device 2 2
Compatibility Problem 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Device Ingredient or Reagent Problem 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
Device Difficult to Maintain 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1498 1498
No Known Impact Or Consequence To Patient 399 399
No Consequences Or Impact To Patient 269 269
Chest Pain 108 108
No Code Available 59 59
Insufficient Information 50 50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
No Information 36 36
High Blood Pressure/ Hypertension 18 18
Pain 17 17
Dizziness 16 16
Abdominal Pain 11 11
Myocardial Infarction 10 10
Respiratory Distress 10 10
Vomiting 8 8
Cardiac Enzyme Elevation 7 7
Fall 6 6
Headache 6 6
Nausea 6 6
Congestive Heart Failure 5 5
Dyspnea 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Unspecified Respiratory Problem 5 5
Heart Failure/Congestive Heart Failure 4 4
Respiratory Failure 4 4
Decreased Respiratory Rate 4 4
Anxiety 4 4
Weakness 4 4
Misdiagnosis 3 3
Pneumonia 3 3
Sore Throat 3 3
Adult Respiratory Distress Syndrome 3 3
Asthma 3 3
Liver Damage/Dysfunction 3 3
Diarrhea 3 3
Ischemic Heart Disease 3 3
Patient Problem/Medical Problem 3 3
Cancer 2 2
Syncope/Fainting 2 2
Cough 2 2
Test Result 2 2
Diabetic Ketoacidosis 2 2
Myocarditis 2 2
Respiratory Insufficiency 2 2
Hyperglycemia 2 2
Pyrosis/Heartburn 2 2
Fatigue 2 2
Fever 2 2
Bone Fracture(s) 2 2
Hypoxia 2 2
Pulmonary Embolism 2 2
Bruise/Contusion 2 2
Cardiac Arrest 2 2
Stroke/CVA 2 2
Neck Pain 2 2
Chest Tightness/Pressure 2 2
Palpitations 2 2
Vertigo 2 2
Tachycardia 2 2
Transient Ischemic Attack 1 1
Urinary Tract Infection 1 1
Ventricular Tachycardia 1 1
ST Segment Elevation 1 1
Seizures 1 1
Sepsis 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Pneumothorax 1 1
Chills 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
Injury 1 1
Hernia 1 1
HIV, Human Immunodeficiency Virus 1 1
Heart Failure 1 1
Breast Cancer 1 1
Encephalopathy 1 1
Dehydration 1 1
Syncope 1 1
Atrial Fibrillation 1 1
Apnea 1 1
Arthritis 1 1
Itching Sensation 1 1
Hyperventilation 1 1
Memory Loss/Impairment 1 1
Intracranial Hemorrhage 1 1
Gastroesophageal Burn 1 1
Limb Fracture 1 1
Skin Disorders 1 1
Swelling/ Edema 1 1
Peripheral Edema 1 1
Confusion/ Disorientation 1 1
Lethargy 1 1
Pulmonary Hypertension 1 1
Unspecified Heart Problem 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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