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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 2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 618 618
2018 487 487
2019 521 521
2020 387 387
2021 356 356
2022 252 252

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 1318 1318
False Positive Result 579 579
False Negative Result 192 192
Low Test Results 135 135
Non Reproducible Results 117 117
Adverse Event Without Identified Device or Use Problem 107 107
No Apparent Adverse Event 107 107
Incorrect, Inadequate or Imprecise Resultor Readings 67 67
Incorrect Or Inadequate Test Results 50 50
High Readings 40 40
Incorrect Measurement 18 18
Device Displays Incorrect Message 9 9
Failure to Obtain Sample 7 7
Insufficient Information 6 6
Low Readings 6 6
Unexpected Therapeutic Results 4 4
Contamination of Device Ingredient or Reagent 4 4
Device Operates Differently Than Expected 4 4
Appropriate Term/Code Not Available 3 3
Use of Device Problem 3 3
Electrical /Electronic Property Problem 2 2
Unable to Obtain Readings 2 2
Patient-Device Incompatibility 1 1
Nonstandard Device 1 1
Product Quality Problem 1 1
Fail-Safe Problem 1 1
Device Ingredient or Reagent Problem 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 916 916
No Clinical Signs, Symptoms or Conditions 532 532
No Consequences Or Impact To Patient 417 417
Chest Pain 181 181
No Information 171 171
No Code Available 138 138
Insufficient Information 39 39
Pain 30 30
Respiratory Distress 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Dizziness 22 22
Misdiagnosis 19 19
High Blood Pressure/ Hypertension 19 19
Myocardial Infarction 15 15
Dyspnea 14 14
Vomiting 13 13
Abdominal Pain 12 12
Congestive Heart Failure 11 11
Chest Tightness/Pressure 11 11
Weakness 10 10
Chronic Obstructive Pulmonary Disease (COPD) 8 8
Fall 8 8
Headache 7 7
Nausea 7 7
Test Result 6 6
Transient Ischemic Attack 5 5
Vertigo 4 4
Pneumonia 4 4
Syncope 4 4
Atrial Fibrillation 4 4
Anxiety 4 4
Discomfort 3 3
Palpitations 3 3
Irregular Pulse 3 3
Respiratory Failure 3 3
Decreased Respiratory Rate 3 3
Ischemic Heart Disease 3 3
Unspecified Respiratory Problem 3 3
No Patient Involvement 3 3
Patient Problem/Medical Problem 3 3
Fever 3 3
Bone Fracture(s) 3 3
Hyperglycemia 3 3
Stroke/CVA 3 3
Diarrhea 3 3
Liver Damage/Dysfunction 3 3
Hypoxia 3 3
Tachycardia 3 3
Heart Failure 3 3
Urinary Tract Infection 2 2
Overdose 2 2
Hypoventilation 2 2
Renal Failure 2 2
Asthma 2 2
Fatigue 2 2
Cardiac Enzyme Elevation 2 2
Pulmonary Embolism 2 2
Bruise/Contusion 2 2
Cardiac Arrest 2 2
Death 2 2
Neck Pain 2 2
Cancer 2 2
Cough 2 2
Confusion/ Disorientation 2 2
Injury 2 2
Diabetic Ketoacidosis 2 2
Sore Throat 1 1
Perforation of Esophagus 1 1
Numbness 1 1
Loss of consciousness 1 1
Respiratory Tract Infection 1 1
Depression 1 1
Electric Shock 1 1
Respiratory Insufficiency 1 1
Gastroesophageal Burn 1 1
Peripheral Edema 1 1
Constipation 1 1
Heart Failure/Congestive Heart Failure 1 1
Diaphoresis 1 1
Dehydration 1 1
Dementia 1 1
Cellulitis 1 1
Atrial Flutter 1 1
Bradycardia 1 1
Bronchitis 1 1
Adult Respiratory Distress Syndrome 1 1
Anemia 1 1
Angina 1 1
Apnea 1 1
Arrhythmia 1 1
Arthritis 1 1
Hyperventilation 1 1
Hypoglycemia 1 1
Glaucoma 1 1
Pyrosis/Heartburn 1 1
Ecchymosis 1 1
Edema 1 1
Dysphagia/ Odynophagia 1 1
Rash 1 1
ST Segment Elevation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Dec-31-2019
2 Beckman Coulter Inc. II Oct-06-2021
3 Roche Diagnostics Operations, Inc. II May-14-2021
4 Siemens Healthcare Diagnostics Inc II Jul-30-2019
5 Siemens Healthcare Diagnostics, Inc. II Jul-06-2022
6 Siemens Healthcare Diagnostics, Inc. II Oct-02-2020
7 Siemens Healthcare Diagnostics, Inc. II Sep-02-2020
8 Siemens Healthcare Diagnostics, Inc. II Jul-13-2018
9 Siemens Healthcare Diagnostics, Inc. II May-04-2018
10 Siemens Healthcare Diagnostics, Inc. II May-05-2017
11 Tosoh Bioscience Inc II Jun-05-2018
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