FDA Adverse Event
Malfunction
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 3874164
·
Received April 23, 2014
Report
- Report Number
- 3007981285-2014-00426
- Event Type
- Malfunction
- Date Received
- April 23, 2014
- Date of Event
- March 29, 2014
- Report Date
- March 29, 2014
- Manufacturer
- TANDEM DIABETES
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Removal / Correction Number
- Z-0827-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RETURNED FOR EVAL. SHOULD NEW INFO BECOME AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
RECEIVED INFO STATING PT EXPERIENCED HIGH BG'S.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245172 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES | 004628 | M001964 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |