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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeOPP
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
CALIBRA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
CEQUR SA
  SUBSTANTIALLY EQUIVALENT 1
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH
  SUBSTANTIALLY EQUIVALENT 1

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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