FDA Adverse Event
Injury
Summary report: N
TANDEM T: SLIM INSULIN DELIVERY SYS
MDR report key: 4076802
·
Received August 26, 2014
Report
- Report Number
- 3007981285-2014-05458
- Event Type
- Injury
- Date Received
- August 26, 2014
- Date of Event
- July 25, 2014
- Report Date
- July 27, 2014
- Manufacturer
- TANDEM DIABETES CARE INC.
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW INFO BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
RECEIVED INFO REGARDING AIR BUBBLES IN THE TUBING. CUSTOMER WAS ABLE TO REMOVE THE AIR BUBBLES THROUGH TROUBLESHOOTING WITH TANDEM'S TECHNICAL SUPPORT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED (170-175 MG/DL).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 515677 | TANDEM T: SLIM INSULIN DELIVERY SYS | INSULIN PUMP | LZG | TANDEM DIABETES CARE INC. | 004628 | M003163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other | INFUSION SET: QUICKSET| INSULIN: NOVOLOG |