FDA Adverse Event
Injury
Summary report: N
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
MDR report key: 4101145
·
Received September 17, 2014
Report
- Report Number
- 3007981285-2014-08503
- Event Type
- Injury
- Date Received
- September 17, 2014
- Date of Event
- August 31, 2014
- Report Date
- September 4, 2014
- Manufacturer
- TANDEM DIABETES CARE INC.
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL FORM WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR THREE DAYS FOR HAVING HIGH BLOOD GLUCOSE LEVELS (599 MG/DL), AND DIABETIC KETOACIDOSIS. IT IS REPORTED THAT PRIOR TO BEING HOSPITALIZED, CUSTOMER WAS HAVING ISSUES WITH THE ADHESIVE OF HER INFUSION SETS. CUSTOMER WAS TREATED WITH INTRAVENOUS INSULIN WHILE IN THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576818 | TANDEM T: SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE INC. | 004628 | M004205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Hospitalization| R |