FDA Adverse Event
Malfunction
Summary report: N
T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 7824767
·
Received August 28, 2018
Report
- Report Number
- 3013756811-2018-29491
- Event Type
- Malfunction
- Date Received
- August 28, 2018
- Date of Event
- August 7, 2018
- Report Date
- August 28, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 0085216200454590471988
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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 ALTITUDE ALARMS OCCURRED WHILE THE CUSTOMER WAS DELIVERING A BOLUS. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 212-228 MG/DL. REPORTEDLY, THE CUSTOMER WAS ABLE TO RELOAD THE EXISTING CARTRIDGE, CLEAR THE ALARM, AND RESUME INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 665211 | T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 | M021278 | 0085216200454590471988 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |