FDA Adverse Event
Malfunction
Summary report: N
TANDEM T: SLIM DELIVERY SYSTEM
MDR report key: 3913066
·
Received May 14, 2014
Report
- Report Number
- 3007981285-2014-00627
- Event Type
- Malfunction
- Date Received
- May 14, 2014
- Date of Event
- April 16, 2014
- Report Date
- April 16, 2014
- Manufacturer
- TANDEM DIABETES
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
RECEIVED INFORMATION STATING PATIENT WAS EXPERIENCING FLUCTUATING BG'S.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288201 | TANDEM T: SLIM DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |