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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
ABBOTT POINT OF CARE, INC
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPOCAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 4
INSTRUMENTATION LABORATORY COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
OPTI MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 2
OPTI MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 10
RADIOMETER MEDICAL APS.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SENDX MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 93 93
2015 55 55
2016 118 118
2017 206 206
2018 174 174
2019 141 141
2020 117 117
2021 147 147
2022 138 138
2023 178 178
2024 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 366 366
Low Test Results 175 175
High Test Results 168 168
Non Reproducible Results 146 146
Incorrect Or Inadequate Test Results 123 123
High Readings 88 88
Low Readings 52 52
Use of Device Problem 44 44
Insufficient Information 39 39
Incorrect Measurement 35 35
Patient Data Problem 31 31
Output Problem 21 21
False Positive Result 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Fluid/Blood Leak 15 15
False Negative Result 15 15
Device Displays Incorrect Message 15 15
Device Operates Differently Than Expected 14 14
Improper or Incorrect Procedure or Method 14 14
Computer Software Problem 14 14
No Device Output 14 14
Erratic Results 14 14
Data Problem 8 8
False Reading From Device Non-Compliance 8 8
Calibration Problem 7 7
Device Handling Problem 7 7
No Apparent Adverse Event 6 6
Unable to Obtain Readings 6 6
Leak/Splash 6 6
Electrical /Electronic Property Problem 6 6
Mechanical Problem 5 5
Failure to Calibrate 5 5
Smoking 4 4
Device Issue 4 4
Product Quality Problem 4 4
Failure to Obtain Sample 3 3
Unintended Ejection 3 3
Overheating of Device 3 3
Coagulation in Device or Device Ingredient 3 3
Break 3 3
Calibration Error 3 3
Program or Algorithm Execution Failure 3 3
Missing Test Results 2 2
Programming Issue 2 2
Optical Problem 2 2
Application Security Problem 2 2
Material Integrity Problem 2 2
Infusion or Flow Problem 2 2
Installation-Related Problem 2 2
Maintenance Does Not Comply To Manufacturers Recommendations 2 2
Use of Incorrect Control/Treatment Settings 2 2
Nonstandard Device 2 2
Device Sensing Problem 2 2
Human-Device Interface Problem 2 2
Connection Problem 2 2
Fitting Problem 2 2
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Obstruction of Flow 1 1
Suction Problem 1 1
Retraction Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Short Fill 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Application Program Problem 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Split 1 1
Date/Time-Related Software Problem 1 1
Defective Device 1 1
Chemical Problem 1 1
Communication or Transmission Problem 1 1
Computer System Security Problem 1 1
Melted 1 1
Application Program Problem: Parameter Calculation Error 1 1
Device Difficult to Setup or Prepare 1 1
Loose or Intermittent Connection 1 1
Filling Problem 1 1
Grounding Malfunction 1 1
Image Display Error/Artifact 1 1
Excess Flow or Over-Infusion 1 1
Inability to Irrigate 1 1
Corroded 1 1
Degraded 1 1
Material Discolored 1 1
Display Difficult to Read 1 1
Fail-Safe Design Failure 1 1
Device Alarm System 1 1
Complete Blockage 1 1
Burst Container or Vessel 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Contamination 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Therapeutic or Diagnostic Output Failure 1 1
Power Problem 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 457 457
No Consequences Or Impact To Patient 419 419
No Known Impact Or Consequence To Patient 246 246
No Information 73 73
Insufficient Information 41 41
No Patient Involvement 25 25
Abnormal Blood Gases 22 22
No Code Available 15 15
Death 13 13
Anemia 11 11
Respiratory Distress 11 11
Exposure to Body Fluids 8 8
Cardiac Arrest 8 8
Not Applicable 7 7
Hyperglycemia 6 6
Septic Shock 6 6
Diabetic Ketoacidosis 6 6
Hyperbilirubinemia 5 5
Chest Pain 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Respiratory Failure 4 4
Complaint, Ill-Defined 3 3
Vomiting 3 3
Electrolyte Imbalance 3 3
Fall 3 3
Hemorrhage/Bleeding 3 3
Pneumonia 3 3
Hypoxia 3 3
Patient Problem/Medical Problem 3 3
Respiratory Insufficiency 3 3
Convulsion/Seizure 2 2
Pregnancy 2 2
Chemical Exposure 2 2
Renal Impairment 2 2
High Blood Pressure/ Hypertension 2 2
Hypoglycemia 2 2
Red Eye(s) 2 2
Renal Failure 2 2
Pain 2 2
Dyspnea 2 2
Abdominal Pain 2 2
Sepsis 2 2
Misdiagnosis 2 2
Jaundice 2 2
Therapeutic Response, Increased 2 2
Brain Injury 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Injury 2 2
Needle Stick/Puncture 2 2
Premature Labor 2 2
Discomfort 2 2
Respiratory Acidosis 2 2
Low Oxygen Saturation 1 1
Increased Respiratory Rate 1 1
Aortic Dissection 1 1
Ischemic Heart Disease 1 1
Lethargy 1 1
Chest Tightness/Pressure 1 1
Sore Throat 1 1
Spinal Cord Injury 1 1
Bronchopneumonia 1 1
Hernia 1 1
Hypernatremia 1 1
Cardiogenic Shock 1 1
Distress 1 1
Heart Failure 1 1
Shock 1 1
Respiratory Distress Syndrome of Newborns 1 1
Seizures 1 1
Bronchitis 1 1
Burn(s) 1 1
Aneurysm 1 1
Apnea 1 1
Asthma 1 1
Atherosclerosis 1 1
Biliary Cirrhosis 1 1
Non specific EKG/ECG Changes 1 1
Pulmonary Emphysema 1 1
Fever 1 1
Congenital Defect/Deformity 1 1
Hepatitis 1 1
Pneumothorax 1 1
Hypoventilation 1 1
Unspecified Infection 1 1
Inflammation 1 1
Muscle Weakness 1 1
Unspecified Kidney or Urinary Problem 1 1
Limb Fracture 1 1
Osteomyelitis 1 1
Blood Loss 1 1
Alteration In Body Temperature 1 1
Full thickness (Third Degree) Burn 1 1
Multiple Organ Failure 1 1
Cancer 1 1
Unspecified Vascular Problem 1 1
Rectal Anastomotic Leakage 1 1
Increased Intra-Peritoneal Volume (IIPV) 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 Abbott Point Of Care Inc. II Mar-27-2014
5 Abbott Point Of Care Inc. II Aug-02-2012
6 Abbott Point Of Care Inc. II Jul-09-2012
7 Abbott Point Of Care Inc. II Mar-10-2011
8 Abbott Point Of Care Inc. II Dec-10-2010
9 Abbott Point Of Care Inc. II Nov-03-2010
10 Abbott Point of Care Inc. II Jan-20-2011
11 Abbott Point of Care Inc. III Jun-18-2009
12 Instrumentation Laboratory II Nov-21-2023
13 Instrumentation Laboratory Co. II Jun-27-2011
14 LifeHealth, LLC II Oct-23-2015
15 LifeHealth, LLC II Jun-27-2015
16 Nova Biomedical Corporation II Jul-13-2017
17 OPTI Medical Systems, Inc II Sep-21-2012
18 Radiometer America Inc II Feb-05-2019
19 Radiometer America Inc II Dec-22-2018
20 Radiometer America Inc II Dec-08-2017
21 Radiometer America Inc II Mar-14-2017
22 Radiometer America Inc II Dec-22-2016
23 Radiometer America Inc II Feb-03-2016
24 Radiometer America Inc II Jun-25-2015
25 Radiometer America Inc II Feb-24-2014
26 Radiometer America Inc II Jan-10-2014
27 Radiometer America Inc II Aug-08-2012
28 Radiometer America Inc II Jul-15-2009
29 Radiometer Medical ApS II Jul-01-2022
30 Radiometer Medical ApS II Jun-15-2021
31 Radiometer Medical ApS II Jul-04-2020
32 Radiometer Medical ApS II Jun-29-2020
33 Radiometer Medical ApS II May-28-2020
34 Radiometer Medical ApS II May-01-2020
35 Radiometer Medical ApS II Apr-22-2020
36 Radiometer Medical ApS II Apr-08-2020
37 Radiometer Medical ApS II Mar-14-2018
38 Roche Diagnostics Operations, Inc. II Jan-23-2017
39 Roche Diagnostics Operations, Inc. II Aug-21-2015
40 Roche Diagnostics Operations, Inc. II Aug-05-2015
41 Roche Diagnostics Operations, Inc. III Oct-10-2014
42 Roche Diagnostics Operations, Inc. II Dec-13-2012
43 Sendx Medical Inc II Nov-05-2012
44 Sendx Medical Inc II Aug-30-2012
45 Sendx Medical Inc II Apr-09-2012
46 Sendx Medical Inc II Nov-10-2009
47 Siemens Healthcare Diagnostics Inc II Dec-21-2023
48 Siemens Healthcare Diagnostics Inc II Aug-28-2023
49 Siemens Healthcare Diagnostics Inc II Mar-03-2023
50 Siemens Healthcare Diagnostics Inc II Jul-12-2022
51 Siemens Healthcare Diagnostics Inc II Jun-26-2020
52 Siemens Healthcare Diagnostics Inc II May-05-2017
53 Siemens Healthcare Diagnostics Inc II Sep-14-2016
54 Siemens Healthcare Diagnostics Inc II Oct-29-2013
55 Siemens Healthcare Diagnostics Inc II Mar-08-2010
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