TPLC - Total Product Life Cycle

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Device	electrode measurement, blood-gases (pco2, po2) and blood ph
Regulation Description	Blood gases (PCO2, PO2) and blood pH test system.
Product Code	CHL
Regulation Number	862.1120
Device Class	2

Premarket Reviews
Manufacturer	Decision
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
RADIOMETER MEDICALS APS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	189	189
High Test Results	100	100
Low Test Results	99	99
High Readings	82	82
Non Reproducible Results	77	77
Low Readings	57	57
Incorrect Measurement	34	34
Output Problem	32	32
Insufficient Information	26	26
Computer Software Problem	24	24
No Device Output	15	15
Erratic Results	15	15
Patient Data Problem	12	12
Mechanical Problem	8	8
Use of Device Problem	8	8
False Negative Result	7	7
Device Displays Incorrect Message	7	7
No Apparent Adverse Event	7	7
Smoking	6	6
Unable to Obtain Readings	6	6
Calibration Problem	5	5
Failure to Calibrate	4	4
Program or Algorithm Execution Failure	4	4
Fluid/Blood Leak	3	3
Improper or Incorrect Procedure or Method	3	3
Overheating of Device	3	3
Product Quality Problem	3	3
Data Problem	3	3
Infusion or Flow Problem	3	3
Leak/Splash	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Missing Test Results	2	2
Optical Problem	2	2
Material Integrity Problem	2	2
Failure to Obtain Sample	2	2
Coagulation in Device or Device Ingredient	2	2
Human-Device Interface Problem	2	2
Electrical /Electronic Property Problem	2	2
False Positive Result	2	2
Device Difficult to Setup or Prepare	1	1
Unintended Ejection	1	1
Material Discolored	1	1
Use of Incorrect Control/Treatment Settings	1	1
Ejection Problem	1	1
Date/Time-Related Software Problem	1	1
Contamination	1	1
Material Deformation	1	1
Defective Device	1	1
Retraction Problem	1	1
Fail-Safe Did Not Operate	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	623	623
Insufficient Information	48	48
No Known Impact Or Consequence To Patient	31	31
No Consequences Or Impact To Patient	28	28
No Information	15	15
Anemia	10	10
Cardiac Arrest	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Vomiting	5	5
Needle Stick/Puncture	5	5
Abdominal Pain	4	4
Respiratory Insufficiency	4	4
Fall	3	3
No Patient Involvement	3	3
Chest Pain	3	3
Diabetic Ketoacidosis	3	3
Sepsis	3	3
Convulsion/Seizure	2	2
No Code Available	2	2
Brain Injury	2	2
Hypoglycemia	2	2
Chronic Obstructive Pulmonary Disease (COPD)	2	2
Respiratory Acidosis	2	2
Respiratory Distress	2	2
Pregnancy	2	2
Exposure to Body Fluids	2	2
Hyperbilirubinemia	2	2
Renal Impairment	2	2
Septic Shock	2	2
Hyperglycemia	2	2
Respiratory Distress Syndrome of Newborns	1	1
Hemorrhage/Bleeding	1	1
Hypoxia	1	1
Aneurysm	1	1
Biliary Cirrhosis	1	1
Limb Fracture	1	1
Pneumonia	1	1
Eye Injury	1	1
Congenital Defect/Deformity	1	1
Unspecified Kidney or Urinary Problem	1	1
Unspecified Vascular Problem	1	1
Pain	1	1
Low Oxygen Saturation	1	1
Respiratory Failure	1	1
Decreased Respiratory Rate	1	1
Dyspnea	1	1
Dehydration	1	1
Cardiogenic Shock	1	1
Jaundice	1	1
Diarrhea	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 Medical ApS	II	Jul-24-2024
5	Radiometer Medical ApS	II	Jul-01-2022
6	Radiometer Medical ApS	II	Jun-15-2021
7	Radiometer Medical ApS	II	Jul-04-2020
8	Radiometer Medical ApS	II	Jun-29-2020
9	Radiometer Medical ApS	II	May-28-2020
10	Radiometer Medical ApS	II	May-01-2020
11	Radiometer Medical ApS	II	Apr-22-2020
12	Radiometer Medical ApS	II	Apr-08-2020
13	Siemens Healthcare Diagnostics Inc	II	Nov-01-2024
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
20	Siemens Healthcare Diagnostics, Inc.	II	Dec-20-2024