FDA Adverse Event
Injury
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 6175575
·
Received December 15, 2016
Report
- Report Number
- 3007981285-2016-24531
- Event Type
- Injury
- Date Received
- December 15, 2016
- Date of Event
- November 22, 2016
- Report Date
- November 29, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS INSULIN INSIDE THE CASE WHEN THE USER CHANGED THE CARTRIDGE. REPORTEDLY, THIS OCCURRED TWO TIMES. THE USER BELIEVES THAT INSULIN WAS LEAKING; HOWEVER, THE EXACT LOCATION WAS UNKNOWN. THE USER'S BLOOD GLUCOSE (BG) LEVEL WAS AS HIGH AS 600 MG/DL WITH LARGE KETONES. THE USER ADDRESSED BG LEVEL WITH A BOLUS AND FLUSHED THE KETONES WITH WATER. THE USER SUCCESSFULLY LOADED A NEW CARTRIDGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 826971 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 | M017119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Other |