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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
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMS DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 105 105
2020 89 89
2021 91 91
2022 60 60
2023 109 109
2024 106 106

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 236 236
High Test Results 180 180
Low Test Results 151 151
Non Reproducible Results 69 69
Output Problem 13 13
Misassembly During Maintenance/Repair 12 12
Incorrect Measurement 10 10
High Readings 7 7
Low Readings 7 7
Mechanical Problem 4 4
No Apparent Adverse Event 3 3
Insufficient Information 3 3
Smoking 2 2
Calibration Problem 2 2
Unable to Obtain Readings 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Chemical Problem 1 1
Improper Chemical Reaction 1 1
Structural Problem 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Failure to Calibrate 1 1
Nonstandard Device 1 1
Collapse 1 1
Electrical /Electronic Property Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 349 349
No Known Impact Or Consequence To Patient 46 46
No Information 42 42
No Consequences Or Impact To Patient 42 42
No Code Available 6 6
Abdominal Pain 6 6
Chest Pain 5 5
High Blood Pressure/ Hypertension 5 5
Nausea 4 4
Pain 4 4
Respiratory Distress 4 4
Hemorrhage/Bleeding 4 4
Unspecified Heart Problem 4 4
Cancer 3 3
Test Result 3 3
Dizziness 3 3
Vomiting 3 3
Muscle Weakness 3 3
Weakness 2 2
Renal Disease, End Stage 2 2
Cardiac Arrest 2 2
Fall 2 2
Fatigue 2 2
Fever 2 2
Anemia 2 2
Confusion/ Disorientation 2 2
Injury 2 2
Diabetic Ketoacidosis 2 2
Heart Failure/Congestive Heart Failure 2 2
Unspecified Respiratory Problem 2 2
Gastrointestinal Hemorrhage 2 2
Liver Failure 1 1
Unspecified Kidney or Urinary Problem 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cough 1 1
Wheezing 1 1
Chest Tightness/Pressure 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Arthralgia 1 1
Heart Failure 1 1
Discomfort 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Aneurysm 1 1
Rheumatoid Arthritis 1 1
Atrial Fibrillation 1 1
Biliary Cirrhosis 1 1
Dehydration 1 1
Dementia 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Head Injury 1 1
Hematoma 1 1
Cataract 1 1
Cellulitis 1 1
Intracranial Hemorrhage 1 1
Hyperglycemia 1 1
Renal Failure 1 1
Cramp(s) 1 1
Sepsis 1 1
Swelling 1 1
Tachycardia 1 1
Tissue Damage 1 1
Pulmonary Embolism 1 1
Low Blood Pressure/ Hypotension 1 1
Peripheral Vascular Disease 1 1
Pleural Effusion 1 1
Overdose 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 Nova Biomedical Corporation II Nov-01-2023
4 Ortho-Clinical Diagnostics II Mar-09-2019
5 Siemens Healthcare Diagnostics Inc II Dec-01-2023
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 Vital Scientific N.V. II Oct-16-2019
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