FDA Adverse Event
Injury
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 4924291
·
Received July 16, 2015
Report
- Report Number
- 3007981285-2015-38928
- Event Type
- Injury
- Date Received
- July 16, 2015
- Date of Event
- June 23, 2015
- Report Date
- June 23, 2015
- Manufacturer
- TANDEM DIABETES CARE INC.
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, THE DEVICE IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES WITH MULTIPLE CARTRIDGE LEAKING. CUSTOMER HAD ELEVATED BLOOD GLUCOSE LEVELS (140-400 MG/DL).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 463419 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE INC. | 004628 | M015476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |