FDA Adverse Event
Injury
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 9370421
·
Received November 25, 2019
Report
- Report Number
- 3013756811-2019-84852
- Event Type
- Injury
- Date Received
- November 25, 2019
- Date of Event
- November 11, 2019
- Report Date
- November 25, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007257
- PMA / PMN Number
- P140015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED, AND SUBSEQUENTLY THE PUMP SHUTDOWN. THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) RANGE OF AROUND 200-530 MG/DL. AN INSULIN PEN WAS ADMINISTERED TO ADDRESS BG. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1165203 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |