TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
AL PACHECO AND ASSOCIATES
	SUBSTANTIALLY EQUIVALENT	1
ALR TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
AMALGAM RX, INC
	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	579	579
Computer Software Problem	380	380
Appropriate Term/Code Not Available	50	50
Application Program Problem: Dose Calculation Error	49	49
Incorrect Software Programming Calculations	33	33
Break	17	17
Patient Device Interaction Problem	10	10
Insufficient Flow or Under Infusion	9	9
Battery Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
No Apparent Adverse Event	4	4
Material Too Rigid or Stiff	4	4
Programming Issue	3	3
Patient Data Problem	3	3
Communication or Transmission Problem	3	3
Data Problem	3	3
Unauthorized Access to Computer System	3	3
Failure to Align	3	3
Application Program Problem	3	3
Use of Device Problem	2	2
Problem with Software Installation	2	2
Material Integrity Problem	2	2
Defective Device	2	2
Connection Problem	2	2
Grounding Malfunction	2	2
Fluid/Blood Leak	2	2
Obstruction of Flow	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Application Program Version or Upgrade Problem	1	1
Excess Flow or Over-Infusion	1	1
Device Inoperable	1	1
Fracture	1	1
Device Operates Differently Than Expected	1	1
Device Operational Issue	1	1
Inaccurate Delivery	1	1
Product Quality Problem	1	1
Display Difficult to Read	1	1
Device Sensing Problem	1	1
Decoupling	1	1
Device Contamination with Chemical or Other Material	1	1
Application Program Problem: Parameter Calculation Error	1	1
Priming Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Device Alarm System	1	1
Device Issue	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	937	937
No Consequences Or Impact To Patient	51	51
No Known Impact Or Consequence To Patient	31	31
Hyperglycemia	14	14
Insufficient Information	11	11
Hypoglycemia	10	10
Death	3	3
Electrolyte Imbalance	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Complaint, Ill-Defined	1	1
Nausea	1	1
Seizures	1	1
Diabetic Ketoacidosis	1	1
Cardiac Arrest	1	1
Overdose	1	1
Vomiting	1	1
Renal Failure	1	1
Ulcer	1	1
Headache	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