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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 2
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMS DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
AWARENESS TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER INC.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DIAMOND DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1
DIAMOND DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ELITECHGROUP VITAL SCIENTIFIC BV
  SUBSTANTIALLY EQUIVALENT 1
INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED)
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 2
MEDICA CORP.
  SUBSTANTIALLY EQUIVALENT 2
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 251 251
2015 158 158
2016 84 84
2017 292 292
2018 158 158
2019 105 105
2020 89 89
2021 91 91
2022 60 60
2023 109 109
2024 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 633 633
High Test Results 396 396
Low Test Results 318 318
Incorrect Or Inadequate Test Results 164 164
Nonstandard Device 116 116
Non Reproducible Results 77 77
Device Operates Differently Than Expected 30 30
High Readings 16 16
Output Problem 13 13
Misassembly During Maintenance/Repair 12 12
Low Readings 10 10
Incorrect Measurement 10 10
False Positive Result 10 10
False Negative Result 5 5
Mechanical Problem 5 5
Insufficient Information 4 4
Adverse Event Without Identified Device or Use Problem 4 4
No Apparent Adverse Event 3 3
False Reading From Device Non-Compliance 3 3
False Device Output 2 2
Smoking 2 2
Calibration Problem 2 2
Calibration Error 2 2
Failure to Calibrate 2 2
Failure of Device to Self-Test 2 2
Fluid/Blood Leak 2 2
Unable to Obtain Readings 2 2
Leak/Splash 1 1
Chemical Problem 1 1
Fitting Problem 1 1
Collapse 1 1
Therapeutic or Diagnostic Output Failure 1 1
Use of Device Problem 1 1
Structural Problem 1 1
Improper Chemical Reaction 1 1
Device Displays Incorrect Message 1 1
Electrical /Electronic Property Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 386 386
No Clinical Signs, Symptoms or Conditions 374 374
No Consequences Or Impact To Patient 265 265
No Information 185 185
No Code Available 41 41
Test Result 32 32
Abdominal Pain 30 30
Pain 25 25
Chest Pain 23 23
High Blood Pressure/ Hypertension 22 22
Nausea 21 21
Respiratory Distress 19 19
Vomiting 18 18
Cancer 10 10
Syncope 9 9
Confusion/ Disorientation 9 9
Weakness 9 9
Overdose 8 8
Hemorrhage/Bleeding 8 8
Dizziness 8 8
Headache 7 7
Anemia 7 7
Fever 7 7
Diarrhea 7 7
Urinary Tract Infection 6 6
Dementia 6 6
Pneumonia 6 6
Renal Disease, End Stage 6 6
Dyspnea 6 6
Atrial Fibrillation 5 5
Fatigue 5 5
Hyperglycemia 5 5
Cardiac Arrest 4 4
Diabetic Ketoacidosis 4 4
Dehydration 4 4
Fall 4 4
Anxiety 4 4
Unspecified Heart Problem 4 4
No Patient Involvement 3 3
Injury 3 3
Chills 3 3
Congestive Heart Failure 3 3
Renal Failure 3 3
Chronic Obstructive Pulmonary Disease (COPD) 3 3
Respiratory Failure 3 3
Cellulitis 3 3
Pulmonary Embolism 3 3
Misdiagnosis 3 3
Sleep Dysfunction 3 3
Heart Failure 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Feb-18-2020
2 Abbott Point Of Care Inc. II Apr-18-2011
3 Beckman Coulter Inc. II Apr-26-2011
4 Horiba Instruments, Inc dba Horiba Medical II Apr-18-2013
5 Mindray DS USA, Inc. dba Mindray North America II Jan-30-2020
6 Nova Biomedical Corporation II Nov-01-2023
7 Ortho-Clinical Diagnostics II Mar-09-2019
8 Ortho-Clinical Diagnostics II Sep-28-2018
9 Ortho-Clinical Diagnostics II Jan-31-2017
10 Ortho-Clinical Diagnostics II Feb-25-2014
11 Radiometer America Inc II Jan-23-2014
12 Siemens Healthcare Diagnostics II Nov-18-2013
13 Siemens Healthcare Diagnostics Inc II Dec-01-2023
14 Siemens Healthcare Diagnostics, Inc. II Jan-03-2022
15 Siemens Healthcare Diagnostics, Inc. II Jul-07-2021
16 Siemens Healthcare Diagnostics, Inc. II Jul-06-2021
17 Siemens Healthcare Diagnostics, Inc. II Jun-16-2021
18 Siemens Healthcare Diagnostics, Inc. II Jan-14-2021
19 Siemens Healthcare Diagnostics, Inc. II Apr-24-2020
20 Siemens Healthcare Diagnostics, Inc. II Mar-02-2020
21 Siemens Healthcare Diagnostics, Inc. II Jan-24-2020
22 Siemens Healthcare Diagnostics, Inc. II Oct-16-2019
23 Siemens Healthcare Diagnostics, Inc. II May-09-2019
24 Siemens Healthcare Diagnostics, Inc. II May-01-2018
25 Siemens Healthcare Diagnostics, Inc. II Oct-30-2015
26 Siemens Healthcare Diagnostics, Inc. II Apr-07-2015
27 Vital Scientific N.V. II Oct-16-2019
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