TPLC - Total Product Life Cycle

• Device: sensor, glucose, invasive, component of automated insulin delivery system
• Definition: The device is intended to measure glucose in interstitial fluid. It is intended to provide those measurements as inputs to appropriately qualified digitally connected devices, including automated insulin dosing systems, as determined by FDA.
• Product Code: SFI
• Device Class: 3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
0	0	0	0	8	0

MDR Year	MDR Reports	MDR Events
2025	142	142
2026	395	395

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	350	350
Incorrect, Inadequate or Imprecise Result or Readings	167	167
Calibration Problem	54	54
Retraction Problem	19	19
Unexpected Therapeutic Results	16	16
Activation Problem	11	11
Break	8	8
Loss of or Failure to Bond	5	5
Material Twisted/Bent	3	3
Activation, Positioning or Separation Problem	1	1
Physical Resistance/Sticking	1	1
Difficult to Remove	1	1
Moisture or Humidity Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Delivered as Unsterile Product	1	1
Device Difficult to Program or Calibrate	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	453	453
Hyperglycemia	38	38
Hypoglycemia	23	23
Hemorrhage/Bleeding	22	22
Needle Stick/Puncture	5	5
Skin Inflammation/ Irritation	2	2
Malaise	2	2
Itching Sensation	1	1
Fever	1	1
Rash	1	1
Pain	1	1
Loss of consciousness	1	1
Bruise/Contusion	1	1