TPLC - Total Product Life Cycle

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Device	calculator, drug dose
Regulation Description	Predictive pulmonary-function value calculator.
Product Code	NDC
Regulation Number	868.1890
Device Class	2

Premarket Reviews
Manufacturer	Decision
AMALGAM RX, INC.
	SUBSTANTIALLY EQUIVALENT	1
COMERGE AG
	SUBSTANTIALLY EQUIVALENT	1
GLOOKO, INC.
	SUBSTANTIALLY EQUIVALENT	1
GNC HOLDINGS, LLC
	SUBSTANTIALLY EQUIVALENT	1
1. K221924 Digital Routines
MEDTRONIC MINIMED
	SUBSTANTIALLY EQUIVALENT	2
MONARCH MEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
MONARCH MEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
UPDOC, INC.
	SUBSTANTIALLY EQUIVALENT	1
VOLUNTIS SA.
	SUBSTANTIALLY EQUIVALENT	2
WELLDOC, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	962	963
Computer Software Problem	421	422
Appropriate Term/Code Not Available	59	60
Adverse Event Without Identified Device or Use Problem	27	27
Data Problem	24	24
Break	24	24
Patient Device Interaction Problem	20	20
Battery Problem	14	14
Insufficient Flow or Under Infusion	13	13
Obstruction of Flow	10	10
Material Integrity Problem	9	9
Key or Button Unresponsive/not Working	8	8
Unauthorized Access to Computer System	5	5
Power Problem	4	4
Communication or Transmission Problem	4	5
Material Too Rigid or Stiff	4	4
Application Program Problem: Dose Calculation Error	4	4
Fluid/Blood Leak	3	3
Device Alarm System	3	3
Failure to Align	3	3
Application Program Problem	3	3
No Apparent Adverse Event	3	3
Priming Problem	3	3
Physical Resistance/Sticking	2	2
Connection Problem	2	2
Defective Device	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Grounding Malfunction	2	2
Circuit Failure	2	2
No Display/Image	2	2
Display or Visual Feedback Problem	1	1
Excess Flow or Over-Infusion	1	1
Mechanical Problem	1	1
Fracture	1	1
Inadequate or Insufficient Training	1	1
Use of Device Problem	1	1
Application Network Problem	1	1
Device Sensing Problem	1	2
Human-Device Interface Problem	1	1
Infusion or Flow Problem	1	1
Application Program Version or Upgrade Problem	1	1
Inaccurate Delivery	1	2
Insufficient Information	1	1
Problem with Software Installation	1	1
Moisture or Humidity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1419	1421
Hyperglycemia	46	46
Hypoglycemia	20	21
Insufficient Information	11	12
Diabetic Ketoacidosis	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Dehydration	1	1
Dyspnea	1	1
Ulcer	1	1
Loss of consciousness	1	1