FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 3955321
·
Received June 16, 2014
Report
- Report Number
- 3007981285-2014-02463
- Event Type
- Malfunction
- Date Received
- June 16, 2014
- Date of Event
- April 16, 2014
- Report Date
- May 16, 2014
- Manufacturer
- TANDEM DIABETES CARE INC.
- Product Code
- LZG
- PMA / PMN Number
- 5111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT RETURNING FOR EVALUATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ALL EVENT INFORMATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
RECEIVED INFORMATION STATING THAT CUSTOMER RECEIVED AN ALTITUDE ALARM. REPORTEDLY, THE CUSTOMER WEARS THE PUMP IN THE SHOWER DAILY AND SWIMS WITH THE PUMP FIVE DAYS PER WEEK. THERE WAS NO REPORTED IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352284 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE INC. | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |