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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Definition A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in response to a user initiated action. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions and also provides historical glucose information, facilitating long-term therapy adjustments.
Product CodePZE
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
11 5 3 4 3 1

MDR Year MDR Reports MDR Events
2019 3231 3231
2020 7221 7221
2021 69065 69065
2022 15548 15548
2023 10611 10611
2024 1904 1904

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 91776 91776
Device Displays Incorrect Message 3522 3522
Unable to Obtain Readings 3397 3397
High Readings 2865 2865
Appropriate Term/Code Not Available 2809 2809
Low Readings 2191 2191
Detachment of Device or Device Component 1093 1093
Application Program Problem 1035 1035
Adverse Event Without Identified Device or Use Problem 968 968
Product Quality Problem 904 904
Device Alarm System 424 424
Failure to Power Up 278 278
No Device Output 100 100
Material Twisted/Bent 51 51
Failure to Fire 44 44
Difficult to Insert 42 42
Premature Discharge of Battery 36 36
Insufficient Information 34 34
Computer Software Problem 32 32
Power Problem 26 26
Data Problem 26 26
Battery Problem 18 18
Defective Device 18 18
Display or Visual Feedback Problem 18 18
Application Program Version or Upgrade Problem 15 15
Patient-Device Incompatibility 15 15
Key or Button Unresponsive/not Working 15 15
Therapeutic or Diagnostic Output Failure 15 15
No Display/Image 13 13
Unintended Electrical Shock 13 13
Component Missing 12 12
Output Problem 11 11
No Audible Alarm 10 10
Failure to Charge 9 9
Application Program Freezes, Becomes Nonfunctional 9 9
Break 9 9
Crack 8 8
Packaging Problem 8 8
Communication or Transmission Problem 7 7
Device Fell 6 6
Activation Failure 6 6
Patient Device Interaction Problem 6 6
Failure to Discharge 5 5
Firing Problem 5 5
Erratic or Intermittent Display 5 5
Device Damaged Prior to Use 5 5
Connection Problem 5 5
Display Difficult to Read 5 5
Compatibility Problem 5 5
Device Sensing Problem 5 5
Defective Component 4 4
Failure to Deliver 4 4
Use of Device Problem 4 4
No Apparent Adverse Event 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Mechanical Problem 4 4
Material Separation 4 4
Protective Measures Problem 4 4
Low Test Results 3 3
Device-Device Incompatibility 3 3
Device Slipped 3 3
Labelling, Instructions for Use or Training Problem 3 3
Difficult or Delayed Activation 3 3
Loss of or Failure to Bond 3 3
Failure to Run on Battery 3 3
Misfire 3 3
Loss of Data 3 3
Fire 3 3
Failure to Sense 3 3
Missing Test Results 2 2
Charging Problem 2 2
Explosion 2 2
Activation Problem 2 2
Nonstandard Device 2 2
Image Display Error/Artifact 2 2
Material Protrusion/Extrusion 2 2
Separation Failure 1 1
Use of Incorrect Control/Treatment Settings 1 1
Unsealed Device Packaging 1 1
Delayed Alarm 1 1
Excessive Heating 1 1
Inadequacy of Device Shape and/or Size 1 1
Accessory Incompatible 1 1
Physical Resistance/Sticking 1 1
Material Deformation 1 1
Calibration Problem 1 1
Premature End-of-Life Indicator 1 1
Failure to Disconnect 1 1
Complete Loss of Power 1 1
Sharp Edges 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Close 1 1
Structural Problem 1 1
Failure to Calibrate 1 1
Activation, Positioning or Separation Problem 1 1
Incorrect Measurement 1 1
Retraction Problem 1 1
Unintended Power Up 1 1
Delivered as Unsterile Product 1 1
Failure to Read Input Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 89197 89197
Hypoglycemia 5237 5237
No Known Impact Or Consequence To Patient 4392 4392
Loss of consciousness 4111 4111
Hyperglycemia 2248 2248
Skin Irritation 1878 1878
Erythema 1226 1226
Itching Sensation 1160 1160
Convulsion/Seizure 1063 1063
Dizziness 952 952
Unspecified Infection 941 941
Insufficient Information 862 862
Pain 745 745
Diaphoresis 699 699
Shaking/Tremors 692 692
Skin Infection 527 527
Skin Inflammation/ Irritation 415 415
Diabetic Ketoacidosis 404 404
Vomiting 383 383
Confusion/ Disorientation 359 359
Purulent Discharge 352 352
Fatigue 351 351
Headache 329 329
Sweating 312 312
Rash 302 302
Nausea 268 268
Seizures 221 221
Swelling 203 203
Muscle Weakness 160 160
No Information 153 153
Malaise 151 151
Swelling/ Edema 148 148
Burn(s) 143 143
Weakness 135 135
Fluid Discharge 134 134
Blurred Vision 134 134
Polydipsia 124 124
Bruise/Contusion 115 115
Discomfort 109 109
Hypersensitivity/Allergic reaction 99 99
Device Embedded In Tissue or Plaque 95 95
Burning Sensation 94 94
Hemorrhage/Bleeding 89 89
Skin Inflammation 82 82
Abscess 75 75
Inflammation 64 64
Coma 62 62
Fall 58 58
Lethargy 52 52
Dehydration 50 50
Fever 39 39
Electric Shock 36 36
Tachycardia 35 35
Fainting 34 34
Abdominal Pain 33 33
Foreign Body In Patient 30 30
Chills 29 29
Cramp(s) /Muscle Spasm(s) 21 21
Skin Burning Sensation 20 20
Caustic/Chemical Burns 20 20
Cognitive Changes 18 18
Numbness 18 18
Hot Flashes/Flushes 17 17
Scarring 17 17
Blister 16 16
Urinary Frequency 15 15
Tingling 14 14
Skin Discoloration 14 14
No Code Available 14 14
Anxiety 13 13
Cellulitis 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Hematoma 12 12
Diarrhea 11 11
Balance Problems 11 11
Palpitations 11 11
Pallor 10 10
Discharge 10 10
Dyspnea 10 10
Chest Pain 10 10
Peeling 10 10
Visual Impairment 9 9
Edema 8 8
Blood Loss 8 8
Shock from Patient Lead(s) 7 7
No Consequences Or Impact To Patient 7 7
Vertigo 6 6
Skin Erosion 6 6
Cramp(s) 5 5
High Blood Pressure/ Hypertension 5 5
Loss of Vision 5 5
Paralysis 5 5
Irritation 4 4
Reaction 4 4
Partial thickness (Second Degree) Burn 4 4
Burn, Thermal 4 4
Abdominal Cramps 4 4
Hypoglycemic Shock 4 4
Contact Dermatitis 3 3
Collapse 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. I Apr-06-2023
2 Cardinal Health Inc. II Jun-23-2021
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