FDA Adverse Event
Malfunction
Summary report: N
T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 7852800
·
Received September 6, 2018
Report
- Report Number
- 3013756811-2018-30758
- Event Type
- Malfunction
- Date Received
- September 6, 2018
- Date of Event
- August 16, 2018
- Report Date
- September 6, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 0085216200454590452617
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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, INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 182-250 MG/DL. REPORTEDLY, CUSTOMER HAD MANUAL INJECTIONS AVAILABLE AS ALTERNATE INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695060 | T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 | 0085216200454590452617 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |