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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 electrode, ion specific, sodium
Product CodeJGS
Regulation Number 862.1665
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMS DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
AWARENESS TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED)
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 292 292
2018 158 158
2019 105 105
2020 89 89
2021 92 92
2022 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 497 497
High Test Results 145 145
Low Test Results 111 111
Non Reproducible Results 31 31
High Readings 14 14
Misassembly During Maintenance/Repair 12 12
False Positive Result 9 9
Low Readings 7 7
Nonstandard Device 7 7
Incorrect Or Inadequate Test Results 7 7
False Negative Result 4 4
Smoking 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Structural Problem 1 1
Device Operates Differently Than Expected 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Collapse 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 177 177
No Clinical Signs, Symptoms or Conditions 136 136
No Known Impact Or Consequence To Patient 110 110
No Consequences Or Impact To Patient 71 71
No Code Available 36 36
Abdominal Pain 29 29
Pain 25 25
Chest Pain 21 21
High Blood Pressure/ Hypertension 21 21
Respiratory Distress 19 19
Nausea 19 19
Vomiting 15 15
Cancer 10 10
Confusion/ Disorientation 9 9
Weakness 9 9
Syncope 9 9
Overdose 8 8
Hemorrhage/Bleeding 7 7
Headache 7 7
Dizziness 7 7
Anemia 7 7
Diarrhea 7 7
Dyspnea 6 6
Fever 6 6
Dementia 6 6
Urinary Tract Infection 6 6
Renal Disease, End Stage 6 6
Pneumonia 6 6
Hyperglycemia 5 5
Atrial Fibrillation 5 5
Fatigue 5 5
Test Result 5 5
Anxiety 4 4
Unspecified Heart Problem 4 4
Dehydration 4 4
Congestive Heart Failure 3 3
Pulmonary Embolism 3 3
Fall 3 3
Chills 3 3
Heart Failure 3 3
Chronic Obstructive Pulmonary Disease (COPD) 3 3
Injury 3 3
Diabetic Ketoacidosis 3 3
Sleep Dysfunction 3 3
Sweating 2 2
Chest Tightness/Pressure 2 2
Respiratory Failure 2 2
Collapse 2 2
Hematuria 2 2
Weight Changes 2 2
Gastrointestinal Hemorrhage 2 2
Cramp(s) 2 2
Burning Sensation 2 2
Sepsis 2 2
Septic Shock 2 2
Swelling 2 2
Renal Failure 2 2
Hematoma 2 2
Gastritis 2 2
Encephalopathy 2 2
Low Blood Pressure/ Hypotension 2 2
Hypoxia 2 2
Abrasion 2 2
Cardiac Arrest 2 2
Cellulitis 2 2
Stroke/CVA 2 2
Cataract 1 1
Cyst(s) 1 1
Abscess 1 1
Biliary Cirrhosis 1 1
Bronchitis 1 1
Arrhythmia 1 1
Rheumatoid Arthritis 1 1
Unspecified Infection 1 1
Inflammation 1 1
Laceration(s) 1 1
Menstrual Irregularities 1 1
Myocardial Infarction 1 1
Fainting 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Dysphagia/ Odynophagia 1 1
Fistula 1 1
Glaucoma 1 1
Head Injury 1 1
Hemorrhage, Subdural 1 1
Hepatitis 1 1
ST Segment Elevation 1 1
Local Reaction 1 1
Peripheral Vascular Disease 1 1
Pleural Effusion 1 1
Thrombosis 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Vertigo 1 1
Hernia 1 1
Urinary Frequency 1 1
Dementia, Dialysis 1 1
Unspecified Kidney or Urinary Problem 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Feb-18-2020
2 Mindray DS USA, Inc. dba Mindray North America II Jan-30-2020
3 Ortho-Clinical Diagnostics II Mar-09-2019
4 Ortho-Clinical Diagnostics II Sep-28-2018
5 Ortho-Clinical Diagnostics II Jan-31-2017
6 Siemens Healthcare Diagnostics, Inc. II Jan-03-2022
7 Siemens Healthcare Diagnostics, Inc. II Jul-07-2021
8 Siemens Healthcare Diagnostics, Inc. II Jul-06-2021
9 Siemens Healthcare Diagnostics, Inc. II Jun-16-2021
10 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
11 Siemens Healthcare Diagnostics, Inc. II Apr-24-2020
12 Siemens Healthcare Diagnostics, Inc. II Mar-02-2020
13 Siemens Healthcare Diagnostics, Inc. II Jan-24-2020
14 Siemens Healthcare Diagnostics, Inc. II Oct-16-2019
15 Siemens Healthcare Diagnostics, Inc. II May-09-2019
16 Siemens Healthcare Diagnostics, Inc. II May-01-2018
17 Vital Scientific N.V. II Oct-16-2019
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