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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
EPOCAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
2019 141 141
2020 117 117
2021 147 147
2022 138 138
2023 178 178
2024 122 122

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 196 196
Non Reproducible Results 136 136
Low Test Results 96 96
High Readings 89 89
High Test Results 86 86
Low Readings 51 51
Insufficient Information 34 34
Incorrect Measurement 29 29
Output Problem 24 24
Computer Software Problem 18 18
No Device Output 14 14
Erratic Results 14 14
Patient Data Problem 12 12
False Negative Result 10 10
Device Displays Incorrect Message 7 7
Use of Device Problem 7 7
No Apparent Adverse Event 6 6
Unable to Obtain Readings 6 6
Smoking 5 5
Mechanical Problem 4 4
Electrical /Electronic Property Problem 4 4
Program or Algorithm Execution Failure 4 4
Failure to Calibrate 4 4
Calibration Problem 4 4
Fluid/Blood Leak 3 3
Improper or Incorrect Procedure or Method 3 3
Overheating of Device 3 3
Failure to Obtain Sample 3 3
Product Quality Problem 3 3
Data Problem 3 3
Human-Device Interface Problem 2 2
Coagulation in Device or Device Ingredient 2 2
Optical Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Infusion or Flow Problem 2 2
Unintended Ejection 2 2
Material Integrity Problem 2 2
Leak/Splash 2 2
Missing Test Results 1 1
Misassembly During Maintenance/Repair 1 1
Use of Incorrect Control/Treatment Settings 1 1
Date/Time-Related Software Problem 1 1
Device Difficult to Setup or Prepare 1 1
Material Deformation 1 1
Material Discolored 1 1
Ejection Problem 1 1
Contamination 1 1
Retraction Problem 1 1
Detachment of Device or Device Component 1 1
Device Sensing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 528 528
No Consequences Or Impact To Patient 92 92
No Known Impact Or Consequence To Patient 71 71
Insufficient Information 45 45
No Information 30 30
No Patient Involvement 11 11
Anemia 10 10
Abnormal Blood Gases 8 8
Cardiac Arrest 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Respiratory Distress 5 5
Abdominal Pain 4 4
Respiratory Insufficiency 4 4
Diabetic Ketoacidosis 4 4
Vomiting 4 4
Exposure to Body Fluids 4 4
Hypoxia 3 3
Fall 3 3
Sepsis 3 3
No Code Available 3 3
Chest Pain 3 3
Needle Stick/Puncture 3 3
Convulsion/Seizure 2 2
Renal Impairment 2 2
Hyperglycemia 2 2
Septic Shock 2 2
Pregnancy 2 2
Respiratory Acidosis 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Brain Injury 2 2
Hyperbilirubinemia 2 2
Electrolyte Imbalance 1 1
Alteration In Body Temperature 1 1
Multiple Organ Failure 1 1
Hepatitis 1 1
Chemical Exposure 1 1
Asthma 1 1
Osteomyelitis 1 1
Muscle Weakness 1 1
Pulmonary Emphysema 1 1
Diarrhea 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Rectal Anastomotic Leakage 1 1
Jaundice 1 1
Cardiogenic Shock 1 1
Nausea 1 1
Dyspnea 1 1
Pancreatitis 1 1
Pain 1 1
Hypoventilation 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 Instrumentation Laboratory II Nov-21-2023
4 Radiometer America Inc II Feb-05-2019
5 Radiometer Medical ApS II Jul-24-2024
6 Radiometer Medical ApS II Jul-01-2022
7 Radiometer Medical ApS II Jun-15-2021
8 Radiometer Medical ApS II Jul-04-2020
9 Radiometer Medical ApS II Jun-29-2020
10 Radiometer Medical ApS II May-28-2020
11 Radiometer Medical ApS II May-01-2020
12 Radiometer Medical ApS II Apr-22-2020
13 Radiometer Medical ApS II Apr-08-2020
14 Siemens Healthcare Diagnostics Inc II Jun-26-2024
15 Siemens Healthcare Diagnostics Inc II Dec-21-2023
16 Siemens Healthcare Diagnostics Inc II Aug-28-2023
17 Siemens Healthcare Diagnostics Inc II Mar-03-2023
18 Siemens Healthcare Diagnostics Inc II Jul-12-2022
19 Siemens Healthcare Diagnostics Inc II Jun-26-2020
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