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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
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
2018 174 174
2019 141 141
2020 117 117
2021 147 147
2022 138 138
2023 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 229 229
Non Reproducible Results 145 145
Low Test Results 83 83
High Readings 79 79
High Test Results 74 74
Low Readings 41 41
Insufficient Information 26 26
Incorrect Measurement 20 20
Incorrect Or Inadequate Test Results 19 19
Patient Data Problem 16 16
Output Problem 16 16
Use of Device Problem 16 16
No Device Output 14 14
Erratic Results 14 14
Computer Software Problem 10 10
False Negative Result 10 10
Adverse Event Without Identified Device or Use Problem 9 9
No Apparent Adverse Event 6 6
Unable to Obtain Readings 6 6
Data Problem 6 6
Fluid/Blood Leak 5 5
Smoking 4 4
Failure to Calibrate 4 4
Calibration Problem 3 3
Mechanical Problem 3 3
Electrical /Electronic Property Problem 3 3
Unintended Ejection 3 3
Program or Algorithm Execution Failure 3 3
Coagulation in Device or Device Ingredient 2 2
Overheating of Device 2 2
Leak/Splash 2 2
Product Quality Problem 2 2
Material Integrity Problem 2 2
Missing Test Results 2 2
Application Security Problem 2 2
Failure to Obtain Sample 2 2
Connection Problem 2 2
Infusion or Flow Problem 2 2
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Device Sensing Problem 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 1 1
Date/Time-Related Software Problem 1 1
Defective Device 1 1
Noise, Audible 1 1
Low pH 1 1
Ejection Problem 1 1
Unexpected Shutdown 1 1
Device Handling Problem 1 1
Appropriate Term/Code Not Available 1 1
Power Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Computer System Security Problem 1 1
Optical Problem 1 1
Device Difficult to Setup or Prepare 1 1
Melted 1 1
Nonstandard Device 1 1
Retraction Problem 1 1
Short Fill 1 1
Suction Problem 1 1
Defective Component 1 1
Device Issue 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Grounding Malfunction 1 1
Image Display Error/Artifact 1 1
Inability to Irrigate 1 1
False Positive Result 1 1
False Reading From Device Non-Compliance 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 Difficult to Read 1 1
Incomplete or Inadequate Connection 1 1
Fail-Safe Did Not Operate 1 1
Misassembly During Maintenance/Repair 1 1
Application Program Freezes, Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 361 361
No Consequences Or Impact To Patient 175 175
No Known Impact Or Consequence To Patient 111 111
No Information 43 43
Insufficient Information 41 41
No Patient Involvement 17 17
Anemia 11 11
Abnormal Blood Gases 11 11
Respiratory Distress 9 9
No Code Available 8 8
Cardiac Arrest 7 7
Death 6 6
Exposure to Body Fluids 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Septic Shock 5 5
Diabetic Ketoacidosis 5 5
Respiratory Failure 4 4
Not Applicable 4 4
Hyperbilirubinemia 4 4
Hypoxia 3 3
Pneumonia 3 3
Chest Pain 3 3
Fall 3 3
Respiratory Insufficiency 3 3
Renal Impairment 2 2
Pregnancy 2 2
Needle Stick/Puncture 2 2
Therapeutic Response, Increased 2 2
Respiratory Acidosis 2 2
Vomiting 2 2
Jaundice 2 2
Brain Injury 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Hemorrhage/Bleeding 2 2
Pain 2 2
Sepsis 2 2
Hyperglycemia 2 2
High Blood Pressure/ Hypertension 2 2
Convulsion/Seizure 2 2
Hypoglycemia 1 1
Hypoventilation 1 1
Unspecified Infection 1 1
Inflammation 1 1
Muscle Weakness 1 1
Respiratory Distress Syndrome of Newborns 1 1
Hepatitis 1 1
Renal Failure 1 1
Fever 1 1
Congenital Defect/Deformity 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Pulmonary Emphysema 1 1
Burn(s) 1 1
Abdominal Pain 1 1
Apnea 1 1
Asthma 1 1
Biliary Cirrhosis 1 1
Cardiogenic Shock 1 1
Spinal Cord Injury 1 1
Chest Tightness/Pressure 1 1
Low Oxygen Saturation 1 1
Increased Respiratory Rate 1 1
Lethargy 1 1
Chemical Exposure 1 1
Multiple Organ Failure 1 1
Alteration In Body Temperature 1 1
Unspecified Kidney or Urinary Problem 1 1
Limb Fracture 1 1
Osteomyelitis 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 Radiometer America Inc II Feb-05-2019
5 Radiometer America Inc II Dec-22-2018
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 Radiometer Medical ApS II Mar-14-2018
15 Siemens Healthcare Diagnostics Inc II Aug-28-2023
16 Siemens Healthcare Diagnostics Inc II Mar-03-2023
17 Siemens Healthcare Diagnostics Inc II Jul-12-2022
18 Siemens Healthcare Diagnostics Inc II Jun-26-2020
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