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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode measurement, blood-gases (pco2, po2) and blood ph
Product CodeCHL
Regulation Number 862.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K200492  i-STAT CG4+ Cartridge with the i-STAT 1 System
EPOCAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 2
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
OPTI MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 206 206
2018 174 174
2019 141 141
2020 117 117
2021 147 147
2022 139 139

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 269 269
Non Reproducible Results 145 145
Low Test Results 84 84
High Readings 70 70
High Test Results 67 67
Incorrect Or Inadequate Test Results 67 67
Use of Device Problem 36 36
Low Readings 33 33
Patient Data Problem 23 23
Insufficient Information 22 22
Incorrect Measurement 20 20
False Positive Result 15 15
Output Problem 14 14
Erratic Results 14 14
Adverse Event Without Identified Device or Use Problem 11 11
Computer Software Problem 11 11
False Negative Result 10 10
Fluid/Blood Leak 7 7
Device Displays Incorrect Message 6 6
Device Operates Differently Than Expected 6 6
Electrical /Electronic Property Problem 5 5
Mechanical Problem 5 5
Failure to Calibrate 5 5
No Apparent Adverse Event 5 5
Smoking 4 4
False Reading From Device Non-Compliance 4 4
Device Issue 4 4
Leak/Splash 4 4
Data Problem 4 4
Unintended Ejection 3 3
Coagulation in Device or Device Ingredient 3 3
Connection Problem 2 2
No Device Output 2 2
Overheating of Device 2 2
Application Security Problem 2 2
Missing Test Results 2 2
Infusion or Flow Problem 2 2
Program or Algorithm Execution Failure 2 2
Unexpected Shutdown 1 1
Human-Device Interface Problem 1 1
Device Handling Problem 1 1
Computer System Security Problem 1 1
Date/Time-Related Software Problem 1 1
Excess Flow or Over-Infusion 1 1
Use of Incorrect Control/Treatment Settings 1 1
Low pH 1 1
Fail-Safe Did Not Operate 1 1
Application Program Problem: Parameter Calculation Error 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Detachment Of Device Component 1 1
Contamination 1 1
Display Difficult to Read 1 1
Image Display Error/Artifact 1 1
Failure to Obtain Sample 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Optical Problem 1 1
Power Problem 1 1
Nonstandard Device 1 1
Break 1 1
Filling Problem 1 1
Suction Problem 1 1
Defective Device 1 1
Calibration Problem 1 1
Detachment of Device or Device Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Ejection Problem 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Inability to Irrigate 1 1
Loose or Intermittent Connection 1 1
Unable to Obtain Readings 1 1
Short Fill 1 1
Component Falling 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Misassembly During Maintenance/Repair 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 273 273
No Clinical Signs, Symptoms or Conditions 260 260
No Known Impact Or Consequence To Patient 145 145
No Information 70 70
Insufficient Information 38 38
No Patient Involvement 21 21
Abnormal Blood Gases 21 21
No Code Available 14 14
Anemia 11 11
Respiratory Distress 10 10
Death 9 9
Not Applicable 6 6
Septic Shock 6 6
Exposure to Body Fluids 6 6
Chest Pain 5 5
Diabetic Ketoacidosis 5 5
Hyperbilirubinemia 5 5
Respiratory Failure 4 4
Cardiac Arrest 4 4
Pneumonia 3 3
Hypoxia 3 3
Patient Problem/Medical Problem 3 3
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Therapeutic Response, Increased 2 2
Hyperglycemia 2 2
Hemorrhage/Bleeding 2 2
Abdominal Pain 2 2
Pregnancy 2 2
Renal Impairment 2 2
Respiratory Acidosis 2 2
Renal Failure 2 2
Dyspnea 2 2
Fall 2 2
Pain 2 2
Needle Stick/Puncture 2 2
Premature Labor 2 2
High Blood Pressure/ Hypertension 2 2
Sepsis 2 2
Cancer 1 1
Rectal Anastomotic Leakage 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Muscle Weakness 1 1
Hernia 1 1
Lethargy 1 1
Aneurysm 1 1
Non specific EKG/ECG Changes 1 1
Fever 1 1
Blood Loss 1 1
Alteration In Body Temperature 1 1
Full thickness (Third Degree) Burn 1 1
Limb Fracture 1 1
Chest Tightness/Pressure 1 1
Sore Throat 1 1
Respiratory Distress Syndrome of Newborns 1 1
Seizures 1 1
Vomiting 1 1
Cardiogenic Shock 1 1
Hypoglycemia 1 1
Unspecified Infection 1 1
Asthma 1 1
Atherosclerosis 1 1
Hypoventilation 1 1
Inflammation 1 1
Pulmonary Emphysema 1 1
Burn(s) 1 1
Spinal Cord Injury 1 1
Low Oxygen Saturation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Multiple Organ Failure 1 1
Convulsion/Seizure 1 1
Aortic Dissection 1 1
Ischemic Heart Disease 1 1
Apnea 1 1
Biliary Cirrhosis 1 1
Bronchitis 1 1
Bronchopneumonia 1 1
Increased Respiratory Rate 1 1
Chemical Exposure 1 1
Jaundice 1 1
Heart Failure 1 1
Brain Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Jan-19-2021
2 Abbott Point Of Care Inc. II Feb-18-2020
3 Abbott Point Of Care Inc. II Dec-14-2018
4 Nova Biomedical Corporation II Jul-13-2017
5 Radiometer America Inc II Feb-05-2019
6 Radiometer America Inc II Dec-22-2018
7 Radiometer America Inc II Dec-08-2017
8 Radiometer America Inc II Mar-14-2017
9 Radiometer Medical ApS II Jul-01-2022
10 Radiometer Medical ApS II Jun-15-2021
11 Radiometer Medical ApS II Jul-04-2020
12 Radiometer Medical ApS II Jun-29-2020
13 Radiometer Medical ApS II May-28-2020
14 Radiometer Medical ApS II May-01-2020
15 Radiometer Medical ApS II Apr-22-2020
16 Radiometer Medical ApS II Apr-08-2020
17 Radiometer Medical ApS II Mar-14-2018
18 Roche Diagnostics Operations, Inc. II Jan-23-2017
19 Siemens Healthcare Diagnostics Inc II Jul-12-2022
20 Siemens Healthcare Diagnostics Inc II Jun-26-2020
21 Siemens Healthcare Diagnostics Inc II May-05-2017
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