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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
Regulation Description Creatine phosphokinase/creatine kinase or isoenzymes test system.
Product CodeMMI
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
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
2016 487 487
2017 618 618
2018 487 487
2019 521 521
2020 387 387
2021 244 244

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 1291 1291
False Positive Result 541 541
False Negative Result 192 192
Incorrect, Inadequate or Imprecise Resultor Readings 178 178
Adverse Event Without Identified Device or Use Problem 145 145
Low Test Results 139 139
No Apparent Adverse Event 107 107
Incorrect Or Inadequate Test Results 86 86
Non Reproducible Results 81 81
High Readings 39 39
Incorrect Measurement 13 13
Device Displays Incorrect Message 9 9
Failure to Obtain Sample 7 7
Low Readings 6 6
Unexpected Therapeutic Results 6 6
Insufficient Information 6 6
Device Operates Differently Than Expected 4 4
Contamination of Device Ingredient or Reagent 4 4
Appropriate Term/Code Not Available 3 3
Electrical /Electronic Property Problem 2 2
Unable to Obtain Readings 2 2
Clumping in Device or Device Ingredient 1 1
Device Ingredient or Reagent Problem 1 1
Fail-Safe Problem 1 1
Application Program Problem: Medication Error 1 1
Device Handling Problem 1 1
Nonstandard Device 1 1
False Device Output 1 1
Patient-Device Incompatibility 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1179 1179
No Consequences Or Impact To Patient 539 539
No Clinical Signs, Symptoms or Conditions 233 233
No Code Available 224 224
No Information 174 174
Chest Pain 167 167
Pain 27 27
Respiratory Distress 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Misdiagnosis 20 20
Insufficient Information 18 18
Dizziness 17 17
Myocardial Infarction 14 14
Dyspnea 14 14
Vomiting 13 13
Abdominal Pain 12 12
High Blood Pressure/ Hypertension 12 12
Congestive Heart Failure 11 11
Chest Tightness/Pressure 11 11
Weakness 10 10
Chronic Obstructive Pulmonary Disease (COPD) 8 8
Test Result 7 7
Fall 7 7
Nausea 6 6
No Patient Involvement 5 5
Patient Problem/Medical Problem 5 5
Transient Ischemic Attack 5 5
Ischemic Heart Disease 4 4
Anxiety 4 4
Pneumonia 4 4
Tachycardia 4 4
Headache 4 4
Hyperglycemia 4 4
Syncope 4 4
Diarrhea 3 3
Atrial Fibrillation 3 3
Liver Damage/Dysfunction 3 3
Discomfort 3 3
Heart Failure 3 3
Vertigo 3 3
Palpitations 3 3
Irregular Pulse 3 3
Fever 3 3
Fatigue 2 2
Hypoventilation 2 2
Pulmonary Embolism 2 2
Respiratory Failure 2 2
Cancer 2 2
Renal Failure 2 2
Injury 2 2
Confusion/ Disorientation 2 2
Sore Throat 2 2
Urinary Tract Infection 2 2
Stroke/CVA 2 2
Hypoxia 2 2
Seizures 2 2
Overdose 2 2
Angina 2 2
Asthma 2 2
Death 2 2
Ecchymosis 1 1
Edema 1 1
Cardiac Enzyme Elevation 1 1
Bone Fracture(s) 1 1
Apnea 1 1
Arrhythmia 1 1
Bradycardia 1 1
Bronchitis 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Thyroid Problems 1 1
Tinnitus 1 1
Unspecified Infection 1 1
Hyperventilation 1 1
Hypoglycemia 1 1
Hemorrhage/Bleeding 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Tingling 1 1
Cardiogenic Shock 1 1
Stenosis 1 1
HIV, Human Immunodeficiency Virus 1 1
Respiratory Tract Infection 1 1
Electric Shock 1 1
Depression 1 1
Missing Value Reason 1 1
Constipation 1 1
Respiratory Insufficiency 1 1
ST Segment Elevation 1 1
Sepsis 1 1
Swelling 1 1
Ventricular Tachycardia 1 1
Cough 1 1
Ulcer 1 1
Perforation of Esophagus 1 1
Numbness 1 1
Neck Pain 1 1
Diaphoresis 1 1
Anemia 1 1
Arthritis 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 Jan-07-2016
6 Siemens Healthcare Diagnostics, Inc II Jun-21-2016
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 Siemens Healthcare Diagnostics, Inc. II May-05-2017
12 Tosoh Bioscience Inc II Jun-05-2018
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