FDA Adverse Event
Other
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 3772129
·
Received March 24, 2014
Report
- Report Number
- 3007981285-2014-00360
- Event Type
- Other
- Date Received
- March 24, 2014
- Date of Event
- February 21, 2014
- Report Date
- February 21, 2014
- Manufacturer
- TANDEM DIABETES
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED. T:SLIM USER GUIDE INDICATES, PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS OF AGE AND GREATER, PT IS (B)(6) YEARS OLD.
Description of Event or Problem · 1
RECEIVED INFORMATION STATING PUMP WAS DELIVERING OCCLUSION ALARMS WHILE IN SCHOOL. SCHOOL NURSE DID NOT KNOW HOW TO RESPOND TO ALARM AND DISMISSED IT. PT EXPERIENCED HIGH BG'S AND KETONES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173552 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES | 004628 | M003380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Other |