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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device continuous glucose monitor, implanted, adjunctive use
Definition The device is a fully implanted continuous glucose monitoring device intended to detect trends and track patterns in interstitial glucose values. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.
Product CodeQCD
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
0 5 8 1 0 1

MDR Year MDR Reports MDR Events
2018 3 3
2019 270 270
2020 594 594
2021 166 166
2022 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Sense 420 420
Imprecision 208 208
Difficult to Remove 187 187
Adverse Event Without Identified Device or Use Problem 143 143
Device Sensing Problem 35 35
Material Separation 29 29
Device Alarm System 26 26
Connection Problem 9 9
Communication or Transmission Problem 8 8
Electrical /Electronic Property Problem 5 5
Insufficient Information 5 5
Intermittent Communication Failure 5 5
Temperature Problem 3 3
No Apparent Adverse Event 2 2
Installation-Related Problem 2 2
Inaccurate Information 2 2
Appropriate Term/Code Not Available 2 2
Malposition of Device 2 2
Calibration Problem 2 2
Charging Problem 1 1
Patient-Device Incompatibility 1 1
Use of Device Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Low Audible Alarm 1 1
Premature Discharge of Battery 1 1
Failure to Charge 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Device Appears to Trigger Rejection 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 239 239
No Known Impact Or Consequence To Patient 237 237
Discomfort 227 227
No Code Available 171 171
Hypoglycemia 145 145
Hyperglycemia 56 56
Post Operative Wound Infection 26 26
Pain 21 21
Unspecified Infection 20 20
Diabetic Ketoacidosis 9 9
No Consequences Or Impact To Patient 7 7
No Information 7 7
Wound Dehiscence 4 4
Cellulitis 3 3
Itching Sensation 3 3
Blood Loss 3 3
Encephalopathy 2 2
Rash 2 2
Local Reaction 2 2
Skin Irritation 2 2
Swelling 1 1
Vomiting 1 1
Scarring 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Pneumonia 1 1
Nausea 1 1
Necrosis 1 1
Stroke/CVA 1 1
Burn(s) 1 1
Anxiety 1 1
Needle Stick/Puncture 1 1
Loss of consciousness 1 1
Fungal Infection 1 1
Sweating 1 1
Missing Value Reason 1 1
Hemorrhagic Stroke 1 1
Heart Failure/Congestive Heart Failure 1 1
Kidney Infection 1 1
Osteomyelitis 1 1
Easy Bruising 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Patient Problem/Medical Problem 1 1

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