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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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

MDR Year MDR Reports MDR Events
2018 158 158
2019 105 105
2020 89 89
2021 92 92
2022 61 61
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 287 287
High Test Results 126 126
Low Test Results 94 94
Non Reproducible Results 32 32
High Readings 13 13
Misassembly During Maintenance/Repair 12 12
Low Readings 6 6
Adverse Event Without Identified Device or Use Problem 2 2
Incorrect Measurement 2 2
Smoking 2 2
Incorrect Or Inadequate Test Results 2 2
Mechanical Problem 2 2
Nonstandard Device 1 1
Collapse 1 1
Output Problem 1 1
Insufficient Information 1 1
Unable to Obtain Readings 1 1
Fitting Problem 1 1
Use of Device Problem 1 1
Structural Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 159 159
No Information 68 68
No Known Impact Or Consequence To Patient 65 65
No Consequences Or Impact To Patient 59 59
No Code Available 20 20
Abdominal Pain 17 17
High Blood Pressure/ Hypertension 15 15
Chest Pain 15 15
Pain 15 15
Respiratory Distress 14 14
Nausea 8 8
Confusion/ Disorientation 8 8
Cancer 6 6
Vomiting 5 5
Hemorrhage/Bleeding 5 5
Renal Disease, End Stage 5 5
Syncope 5 5
Test Result 5 5
Anemia 5 5
Weakness 4 4
Diabetic Ketoacidosis 4 4
Unspecified Heart Problem 4 4
Overdose 4 4
Urinary Tract Infection 4 4
Dizziness 4 4
Dementia 4 4
Fever 3 3
Injury 3 3
Pneumonia 3 3
Atrial Fibrillation 3 3
Hyperglycemia 3 3
Dehydration 3 3
Sleep Dysfunction 3 3
Fatigue 2 2
Burning Sensation 2 2
Gastrointestinal Hemorrhage 2 2
Heart Failure 2 2
Swelling 2 2
Cramp(s) 2 2
Fall 2 2
Respiratory Failure 2 2
Hypoxia 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Cardiac Arrest 2 2
Diarrhea 2 2
Congestive Heart Failure 2 2
Abscess 1 1
Dysphagia/ Odynophagia 1 1
Encephalopathy 1 1
Hernia 1 1
Neck Pain 1 1
Hematuria 1 1
Hepatitis 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Insufficient Information 1 1
Fistula 1 1
Unspecified Infection 1 1
Intermenstrual Bleeding 1 1
Discomfort 1 1
Weight Changes 1 1
Local Reaction 1 1
Myocardial Infarction 1 1
Dysuria 1 1
Renal Failure 1 1
Urinary Frequency 1 1
Hematoma 1 1
Low Blood Pressure/ Hypotension 1 1
Dyspnea 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pregnancy 1 1
Chills 1 1
Pulmonary Embolism 1 1
Abrasion 1 1
Cataract 1 1
Cyst(s) 1 1
Intracranial Hemorrhage 1 1
ST Segment Elevation 1 1
Septic Shock 1 1
Arthralgia 1 1
Peripheral Vascular Disease 1 1
Tissue Damage 1 1
Biliary Cirrhosis 1 1
Cellulitis 1 1
Anxiety 1 1
Chest Tightness/Pressure 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Pleural Effusion 1 1
Tachycardia 1 1
Unspecified Kidney or Urinary Problem 1 1
Gastritis 1 1
Muscle Weakness 1 1
Sepsis 1 1
Rheumatoid Arthritis 1 1
Dementia, Dialysis 1 1
Lethargy 1 1
Heart Failure/Congestive Heart Failure 1 1
Cough 1 1
Unspecified Respiratory Problem 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 Siemens Healthcare Diagnostics, Inc. II Jan-03-2022
6 Siemens Healthcare Diagnostics, Inc. II Jul-07-2021
7 Siemens Healthcare Diagnostics, Inc. II Jul-06-2021
8 Siemens Healthcare Diagnostics, Inc. II Jun-16-2021
9 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
10 Siemens Healthcare Diagnostics, Inc. II Apr-24-2020
11 Siemens Healthcare Diagnostics, Inc. II Mar-02-2020
12 Siemens Healthcare Diagnostics, Inc. II Jan-24-2020
13 Siemens Healthcare Diagnostics, Inc. II Oct-16-2019
14 Siemens Healthcare Diagnostics, Inc. II May-09-2019
15 Siemens Healthcare Diagnostics, Inc. II May-01-2018
16 Vital Scientific N.V. II Oct-16-2019
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