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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 147 147

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 198 198
Non Reproducible Results 137 137
Low Test Results 97 97
High Test Results 91 91
High Readings 90 90
Low Readings 51 51
Insufficient Information 34 34
Incorrect Measurement 32 32
Output Problem 27 27
Computer Software Problem 20 20
No Device Output 14 14
Erratic Results 14 14
Patient Data Problem 14 14
False Negative Result 10 10
Use of Device Problem 9 9
Device Displays Incorrect Message 7 7
No Apparent Adverse Event 6 6
Unable to Obtain Readings 6 6
Mechanical Problem 6 6
Smoking 5 5
Failure to Calibrate 4 4
Calibration Problem 4 4
Program or Algorithm Execution Failure 4 4
Fluid/Blood Leak 4 4
Electrical /Electronic Property Problem 4 4
Product Quality Problem 3 3
Overheating of Device 3 3
Improper or Incorrect Procedure or Method 3 3
Failure to Obtain Sample 3 3
Data Problem 3 3
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Optical Problem 2 2
Human-Device Interface Problem 2 2
Infusion or Flow Problem 2 2
Unintended Ejection 2 2
Leak/Splash 2 2
Coagulation in Device or Device Ingredient 2 2
False Positive Result 1 1
Filling Problem 1 1
Contamination 1 1
Use of Incorrect Control/Treatment Settings 1 1
Corroded 1 1
Material Discolored 1 1
Display or Visual Feedback Problem 1 1
Grounding Malfunction 1 1
Image Display Error/Artifact 1 1
Inability to Irrigate 1 1
Melted 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 548 548
No Consequences Or Impact To Patient 92 92
No Known Impact Or Consequence To Patient 71 71
Insufficient Information 46 46
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
Exposure to Body Fluids 5 5
Needle Stick/Puncture 5 5
Abdominal Pain 4 4
Respiratory Insufficiency 4 4
Diabetic Ketoacidosis 4 4
Vomiting 4 4
Hypoxia 3 3
Fall 3 3
Sepsis 3 3
No Code Available 3 3
Chest Pain 3 3
Convulsion/Seizure 2 2
Hypoglycemia 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
Alteration In Body Temperature 1 1
Electrolyte Imbalance 1 1
Hepatitis 1 1
Multiple Organ Failure 1 1
Chemical Exposure 1 1
Osteomyelitis 1 1
Asthma 1 1
Muscle Weakness 1 1
Diarrhea 1 1
Pulmonary Emphysema 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Jaundice 1 1
Cardiogenic Shock 1 1
Rectal Anastomotic Leakage 1 1
Dyspnea 1 1
Nausea 1 1
Pain 1 1
Pancreatitis 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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