FDA Adverse Event
Malfunction
Summary report: N
T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 8740889
·
Received June 27, 2019
Report
- Report Number
- 3013756811-2019-36212
- Event Type
- Malfunction
- Date Received
- June 27, 2019
- Date of Event
- June 4, 2019
- Report Date
- June 27, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004361
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 MULTIPLE MINIMUM FILL NOTIFICATIONS OCCURRED AFTER FILLING MULTIPLE CARTRIDGES WITH 300 UNITS OF INSULIN. BLOOD GLUCOSE RANGED FROM 130-300 MG/DL. REPORTEDLY, THE CUSTOMER LOADED A NEW CARTRIDGE AND CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535271 | T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 | 00852162004361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |