FDA Adverse Event
Malfunction
Summary report: N
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
MDR report key: 3913040
·
Received May 14, 2014
Report
- Report Number
- 3007981285-2014-00626
- 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SCREEN ON/QUICK BOLUS BUTTON HAS STOPPED FUNCTIONING AND THE PUMP WILL NOT TURN ON UNLESS PLUGGED INTO A POWER SOURCE. THIS ISSUE RESULTED IN THE CUSTOMER HAVING HIGH BLOOD GLUCOSE LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288145 | TANDEM T: SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |