TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
AL PACHECO AND ASSOCIATES
	SUBSTANTIALLY EQUIVALENT	1
ALR TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
COMPANION MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
ELI LILLY AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
GLOOKO, INC
	SUBSTANTIALLY EQUIVALENT	1
GLYTEC, LLC
	SUBSTANTIALLY EQUIVALENT	2
GLYTEC, LLC (FORMALLY KNOWN AS GLUCOTEC, INC.)
	SUBSTANTIALLY EQUIVALENT	1
GNC HOLDINGS, LLC
	SUBSTANTIALLY EQUIVALENT	1
HYGIEIA, INC
	SUBSTANTIALLY EQUIVALENT	1
INSULIN ALGORITHMS
	SUBSTANTIALLY EQUIVALENT	1
ISAG RX, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL DECISION NETWORK
	SUBSTANTIALLY EQUIVALENT	1
MONARCH MEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
MONARCH MEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	3
PICIS INC.
	SUBSTANTIALLY EQUIVALENT	1
REACH HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIABETES CARE INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SANOFI
	SUBSTANTIALLY EQUIVALENT	1
SANOFI, INC.
	SUBSTANTIALLY EQUIVALENT	1
VOLUNTIS S.A.
	SUBSTANTIALLY EQUIVALENT	3
VOLUNTIS SA.
	SUBSTANTIALLY EQUIVALENT	1
VOLUNTIS, S.A.
	SUBSTANTIALLY EQUIVALENT	1
WELLDOC, INC
	SUBSTANTIALLY EQUIVALENT	1
WELLDOC, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	544	544
Computer Software Problem	363	363
Application Program Problem: Dose Calculation Error	49	49
Appropriate Term/Code Not Available	48	48
Incorrect Software Programming Calculations	33	33
Break	16	16
Patient Device Interaction Problem	10	10
Insufficient Flow or Under Infusion	8	8
Battery Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
No Apparent Adverse Event	4	4
Programming Issue	3	3
Unauthorized Access to Computer System	3	3
Application Program Problem	3	3
Communication or Transmission Problem	3	3
Failure to Align	3	3
Material Too Rigid or Stiff	3	3
Data Problem	3	3
Patient Data Problem	3	3
Fluid/Blood Leak	2	2
Grounding Malfunction	2	2
Defective Device	2	2
Use of Device Problem	2	2
Connection Problem	2	2
Problem with Software Installation	2	2
Material Integrity Problem	2	2
Application Program Version or Upgrade Problem	1	1
Device Operates Differently Than Expected	1	1
Device Operational Issue	1	1
Device Sensing Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Improper or Incorrect Procedure or Method	1	1
Excess Flow or Over-Infusion	1	1
Application Program Problem: Parameter Calculation Error	1	1
Fracture	1	1
Device Alarm System	1	1
Decoupling	1	1
Display Difficult to Read	1	1
Device Inoperable	1	1
Product Quality Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Inaccurate Delivery	1	1
Device Issue	1	1
Obstruction of Flow	1	1
Priming Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	885	885
No Consequences Or Impact To Patient	51	51
No Known Impact Or Consequence To Patient	31	31
Hyperglycemia	13	13
Insufficient Information	11	11
Hypoglycemia	10	10
Death	3	3
Electrolyte Imbalance	2	2
Cardiac Arrest	1	1
Headache	1	1
Nausea	1	1
Overdose	1	1
Renal Failure	1	1
Seizures	1	1
Vomiting	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Ulcer	1	1
Complaint, Ill-Defined	1	1
Diabetic Ketoacidosis	1	1
Loss of consciousness	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Companion Medical, Inc.	II	Dec-20-2022
2	Monarch Medical Technologies	II	Nov-08-2019
3	Monarch Medical Technologies	II	Jun-15-2019
4	Roche Diabetes Care, Inc.	II	Sep-26-2019
5	Roche Diabetes Care, Inc.	II	Feb-15-2018
6	Roche Diabetes Care, Inc.	II	Dec-06-2017
7	Roche Diabetes Care, Inc.	II	May-01-2017
8	Roche Diabetes Care, Inc.	II	Jan-26-2017
9	Roche Diabetes Care, Inc.	II	Nov-16-2016
10	Voluntis	II	Nov-17-2018