TPLC - Total Product Life Cycle

show TPLC since

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 Code	QCD
Device Class	3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
4	0	0	0	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Imprecision	441	441
Failure to Sense	411	411
Adverse Event Without Identified Device or Use Problem	325	325
Difficult to Remove	154	154
Device Sensing Problem	34	34
Material Separation	28	28
Device Alarm System	28	28
Insufficient Information	14	14
Communication or Transmission Problem	10	10
Connection Problem	10	10
Electrical /Electronic Property Problem	10	10
Overheating of Device	9	9
Intermittent Communication Failure	5	5
Device Appears to Trigger Rejection	4	4
Calibration Problem	4	4
Temperature Problem	3	3
No Apparent Adverse Event	2	2
Inaccurate Information	2	2
Malposition of Device	2	2
Installation-Related Problem	2	2
Appropriate Term/Code Not Available	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Off-Label Use	1	1
Product Quality Problem	1	1
Low Audible Alarm	1	1
Premature Discharge of Battery	1	1
Failure to Charge	1	1
Device Handling Problem	1	1
Device Fell	1	1
Excessive Heating	1	1
Output Problem	1	1
Power Problem	1	1
Protective Measures Problem	1	1
Activation, Positioning or Separation Problem	1	1
Patient-Device Incompatibility	1	1
Battery Problem	1	1
Charging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypoglycemia	332	332
No Clinical Signs, Symptoms or Conditions	267	267
No Known Impact Or Consequence To Patient	237	237
Discomfort	213	213
No Code Available	171	171
Hyperglycemia	121	121
Skin Infection	60	60
Unspecified Infection	46	46
Pain	46	46
Abscess	30	30
Post Operative Wound Infection	26	26
Skin Inflammation/ Irritation	21	21
Swelling/ Edema	17	17
Diabetic Ketoacidosis	10	10
Fluid Discharge	9	9
Hemorrhage/Bleeding	9	9
Inflammation	8	8
Itching Sensation	7	7
No Consequences Or Impact To Patient	7	7
No Information	7	7
Implant Pain	6	6
Dizziness	5	5
Nausea	5	5
Wound Dehiscence	5	5
Insufficient Information	4	4
Blood Loss	3	3
Numbness	3	3
Cellulitis	3	3
Rash	3	3
Local Reaction	2	2
Skin Irritation	2	2
Encephalopathy	2	2
Bone Fracture(s)	2	2
Easy Bruising	2	2
Fibrosis	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypoglycemic Shock	1	1
Patient Problem/Medical Problem	1	1
Subcutaneous Nodule	1	1
Nodule	1	1
Loss of consciousness	1	1
Fungal Infection	1	1
Sweating	1	1
Needle Stick/Puncture	1	1
Shaking/Tremors	1	1
Lethargy	1	1
Missing Value Reason	1	1
Convulsion/Seizure	1	1
Hemorrhagic Stroke	1	1
Heart Failure/Congestive Heart Failure	1	1
Kidney Infection	1	1
Vertebral Fracture	1	1
Osteomyelitis	1	1
Angioedema	1	1
Blister	1	1
Hematoma	1	1
Erythema	1	1
Fever	1	1
Stroke/CVA	1	1
Bacterial Infection	1	1
Burn(s)	1	1
Hypersensitivity/Allergic reaction	1	1
Laceration(s)	1	1
Swelling	1	1
Vomiting	1	1
Burning Sensation	1	1
Myalgia	1	1
Neurogenic Shock	1	1
Anxiety	1	1
Scar Tissue	1	1
Scarring	1	1
Skin Discoloration	1	1
Skin Erosion	1	1
Necrosis	1	1
Undesired Nerve Stimulation	1	1
Pneumonia	1	1