FDA Adverse Event
Injury
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 4142654
·
Received October 2, 2014
Report
- Report Number
- 3007981285-2014-08578
- Event Type
- Injury
- Date Received
- October 2, 2014
- Date of Event
- September 8, 2014
- Report Date
- September 8, 2014
- Manufacturer
- TANDEM DIABETES CARE INC.
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FOLLOW UP WITH THE CUSTOMER ON (B)(4) 2014 INDICATED THAT THE CUSTOMER LOADED A NEW CARTRIDGE AND INSULIN DELIVERY WAS RESUMED. CUSTOMER HAD ADMINISTERED A MANUAL CORRECTION BOLUS TO MANAGE HIGH BGS. THE PRODUCT HAS NOT BEEN 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 THE CUSTOMER RECEIVED AN ALTITUDE ALARM. REPORTEDLY, THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS IMPACTED (358 MG/DL).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 615412 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE INC. | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |