TPLC - Total Product Life Cycle

show TPLC since

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
GNC HOLDINGS, LLC
	SUBSTANTIALLY EQUIVALENT	1
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	934	935
Computer Software Problem	414	415
Appropriate Term/Code Not Available	58	59
Patient Device Interaction Problem	20	20
Data Problem	20	20
Break	18	18
Insufficient Flow or Under Infusion	10	10
Material Integrity Problem	8	8
Battery Problem	7	7
Material Too Rigid or Stiff	4	4
Application Program Problem: Dose Calculation Error	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Unauthorized Access to Computer System	4	4
Communication or Transmission Problem	3	4
Failure to Align	3	3
No Apparent Adverse Event	3	3
Priming Problem	3	3
Fluid/Blood Leak	3	3
Physical Resistance/Sticking	2	2
Application Program Problem	2	2
Defective Device	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Grounding Malfunction	2	2
Device Alarm System	1	1
Application Program Version or Upgrade Problem	1	1
Problem with Software Installation	1	1
Use of Device Problem	1	1
Obstruction of Flow	1	1
Excess Flow or Over-Infusion	1	1
Infusion or Flow Problem	1	1
Device Sensing Problem	1	2
Inaccurate Delivery	1	2
Fracture	1	1
Application Network Problem	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1357	1359
Hyperglycemia	22	22
Insufficient Information	11	12
Hypoglycemia	7	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Diabetic Ketoacidosis	1	1
Ulcer	1	1