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TPLC
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Device
pump, infusion, insulin bolus
Definition
The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
Product Code
OPP
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
CALIBRA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
CEQUR SA
SUBSTANTIALLY EQUIVALENT
1
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH
SUBSTANTIALLY EQUIVALENT
1
1. K163357
OneTouch Via On-Demand Insulin Delivery System
MDR Year
MDR Reports
MDR Events
2015
22
22
2016
3
3
2017
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Dislodged or Dislocated
7
7
Loss of or Failure to Bond
6
6
Leak/Splash
3
3
Device Difficult to Setup or Prepare
3
3
Human-Device Interface Problem
3
3
Defective Component
3
3
Moisture or Humidity Problem
2
2
Insufficient Information
2
2
Unintended Collision
2
2
Air Leak
2
2
Fluid/Blood Leak
2
2
Failure To Adhere Or Bond
1
1
Bent
1
1
Detachment Of Device Component
1
1
Contamination
1
1
Failure to Read Input Signal
1
1
Sticking
1
1
Material Integrity Problem
1
1
Device Issue
1
1
Malposition of Device
1
1
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
18
18
No Consequences Or Impact To Patient
7
7
Unspecified Infection
4
4
Hyperglycemia
2
2
Dehydration
1
1
Palpitations
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zyno Medical LLC
II
Mar-29-2013
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