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TPLC
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Device
electrode, ion specific, sodium
Regulation Description
Sodium test system.
Product Code
JGS
Regulation Number
862.1665
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
ABBOTT POINT OF CARE INC.
SUBSTANTIALLY EQUIVALENT
1
ABBOTT POINT OF CARE, INC.
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NOVA BIOMEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
89
89
2021
91
91
2022
60
60
2023
109
109
2024
149
149
2025
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
193
193
Incorrect, Inadequate or Imprecise Result or Readings
180
180
Low Test Results
154
154
Non Reproducible Results
74
74
Output Problem
14
14
Incorrect Measurement
12
12
Low Readings
8
8
High Readings
5
5
Insufficient Information
4
4
No Apparent Adverse Event
3
3
Mechanical Problem
3
3
Unable to Obtain Readings
2
2
Smoking
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Calibration Problem
2
2
Chemical Problem
1
1
Nonstandard Device
1
1
Electrical /Electronic Property Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Improper Chemical Reaction
1
1
Failure to Calibrate
1
1
Use of Device Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
403
403
No Known Impact Or Consequence To Patient
22
22
No Consequences Or Impact To Patient
21
21
No Information
11
11
High Blood Pressure/ Hypertension
4
4
Unspecified Heart Problem
4
4
Chest Pain
3
3
Abdominal Pain
3
3
Muscle Weakness
3
3
Hemorrhage/Bleeding
3
3
Pain
3
3
Fall
2
2
Heart Failure/Congestive Heart Failure
2
2
Gastrointestinal Hemorrhage
2
2
Cardiac Arrest
2
2
Nausea
2
2
Unspecified Respiratory Problem
2
2
Confusion/ Disorientation
2
2
Vomiting
2
2
Fatigue
2
2
Dizziness
2
2
Respiratory Distress
2
2
Diabetic Ketoacidosis
2
2
Low Blood Pressure/ Hypotension
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Heart Failure
1
1
Head Injury
1
1
Intracranial Hemorrhage
1
1
Anemia
1
1
Cellulitis
1
1
Unspecified Kidney or Urinary Problem
1
1
Respiratory Failure
1
1
Fever
1
1
Hyperglycemia
1
1
Tachycardia
1
1
Cataract
1
1
Rheumatoid Arthritis
1
1
Arthralgia
1
1
Test Result
1
1
Wheezing
1
1
Aneurysm
1
1
Liver Failure
1
1
Cough
1
1
Respiratory Acidosis
1
1
Insufficient Information
1
1
Biliary Cirrhosis
1
1
Renal Failure
1
1
Hematoma
1
1
Renal Disease, End Stage
1
1
Dehydration
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
Siemens Healthcare Diagnostics Inc
II
Dec-01-2023
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
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