FDA Adverse Event
Injury
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 6107645
·
Received November 16, 2016
Report
- Report Number
- 3007981285-2016-20158
- Event Type
- Injury
- Date Received
- November 16, 2016
- Date of Event
- October 30, 2016
- Report Date
- October 30, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS THAT MULTIPLE OCCLUSION ALARMS OCCURRED DURING BASAL DELIVERY. THE CUSTOMER REPORTED BLOOD GLUCOSE (BG) LEVELS BETWEEN 210-364 (MG/DL). A BOLUS WAS DELIVERED TO ADDRESS BG LEVELS. THE CUSTOMER DECLINED TO COMPLETE ALL THE TROUBLESHOOTING STEPS WITH TANDEM TECHNICAL SUPPORT TO DETERMINE THE SOURCE OF THE OCCLUSION AND INSTEAD OPTED TO CHANGE OUT THEIR INFUSION SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756422 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other |